U.S. patent application number 17/279000 was filed with the patent office on 2021-12-30 for stent graft systems and methods with cuff and limb.
The applicant listed for this patent is Endologix LLC. Invention is credited to Dale Ehnes, Mark Geusen, Ryan Goff, Dennis Parson, Kaushik Patel, Christopher Staudenmayer, Aric Stone, Dion Thurow, Craig Welk, Teri Woodson.
Application Number | 20210401566 17/279000 |
Document ID | / |
Family ID | 1000005852392 |
Filed Date | 2021-12-30 |
United States Patent
Application |
20210401566 |
Kind Code |
A1 |
Geusen; Mark ; et
al. |
December 30, 2021 |
STENT GRAFT SYSTEMS AND METHODS WITH CUFF AND LIMB
Abstract
A stent graft system includes a first graft, a second graft, and
a third graft. Each of the first graft, the second graft, and the
third graft forms a single lumen. When deployed, the first graft,
the second graft, and the third graft are coupled together within
an aorta.
Inventors: |
Geusen; Mark; (Irvine,
CA) ; Woodson; Teri; (Irvine, CA) ;
Staudenmayer; Christopher; (Irvine, CA) ; Parson;
Dennis; (Irvine, CA) ; Thurow; Dion; (Irvine,
CA) ; Goff; Ryan; (Irvine, CA) ; Patel;
Kaushik; (Irvine, CA) ; Stone; Aric; (Irvine,
CA) ; Ehnes; Dale; (Irvine, CA) ; Welk;
Craig; (Irvine, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Endologix LLC |
Irvine |
CA |
US |
|
|
Family ID: |
1000005852392 |
Appl. No.: |
17/279000 |
Filed: |
September 23, 2019 |
PCT Filed: |
September 23, 2019 |
PCT NO: |
PCT/US2019/052459 |
371 Date: |
March 23, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62735771 |
Sep 24, 2018 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/07 20130101; A61F
2250/006 20130101; A61F 2002/067 20130101; A61F 2250/0003 20130101;
A61F 2002/077 20130101 |
International
Class: |
A61F 2/07 20060101
A61F002/07 |
Claims
1. A stent graft system, comprising: a first graft; a second graft;
and a third graft, wherein each of the first graft, the second
graft, and the third graft are separate grafts before being
deployed and each comprises at least one lumen; wherein the second
graft and the third graft are configured to be inserted into the
lumen of the first graft when deployed.
2.-4. (canceled)
5. The stent graft system of claim 1, further comprising: a seal
component coupled to the first graft, the seal component forms a
seal in a proximal neck region of the aorta.
6. The stent graft system of claim 5, wherein the system further
comprises an inflatable fill structure at least partially
surrounding the first graft, the fill structure being configured to
expand within and contact the aorta wall.
7. The stent graft system of claim 5, further comprising an anchor
coupled to the first graft.
8. The stent graft system of claim 5, wherein the inflatable fill
structure, when deployed, at least partially surrounds proximal
ends of the second graft and the third graft that are docked within
the single lumen of the first graft.
9. The stent graft system of claim 5, wherein the inflatable fill
structure is coupled to the first graft; the second graft and the
third graft dock within the single lumen of the first graft in a
docking zone; and the inflatable fill structure, in an inflated
state, surrounds at least portions of the second graft and the
third graft that are outside of the docking zone.
10.-12. (canceled)
13. The stent graft system of claim 5, wherein the second graft and
the third graft dock within the single lumen of the first graft in
a docking zone; and the first graft comprises a wire-wound stent
component coupled to a portion of the first graft in the docking
zone, the wire-wound stent component comprises a plurality of
wire-wound rings.
14. (canceled)
15. The stent graft system of claim 5, wherein the second graft and
the third graft dock within the single lumen of the first graft in
a docking zone; the first graft comprises a wire-wound stent ring
coupled to a portion of the first graft in the docking zone, the
wire-wound stent ring comprises a single ring of wire-wound
stent.
16. (canceled)
17. The stent graft system of claim 5, wherein the inflatable fill
structure forms a funnel shape in an inflated state.
18. (canceled)
19. The stent graft system of claim 5, wherein the inflatable fill
structure is a bifurcated inflatable fill structure that, when in
an inflated state, forms two lumens for receiving the second graft
and the third graft.
20. The stent graft system of claim 1, further comprises a first
inflatable fill structure at least partially surrounding the first
graft; a second inflatable fill structure at least partially
surrounding the second graft; and a third inflatable fill structure
at least partially surrounding the third graft, the first
inflatable fill structure, the second inflatable fill structure,
and the third inflatable fill structure are separate inflatable
fill structures that expand within the aorta when deployed.
21.-24. (canceled)
25. The stent graft system of claim 1, further comprising: a first
inflatable fill structure at least partially surrounding the second
graft; and a second inflatable fill structure at least partially
surrounding the third graft, wherein the first inflatable fill
structure and the second inflatable fill structure expand within
the aorta and surrounds at least partially the first graft when
deployed.
26. The stent graft system of claim 25, wherein each of the second
graft and the third graft comprises a wire-wound stent component,
the wire-wound stent component comprises a plurality of wire-wound
rings.
27.-34. (canceled)
35. The stent graft system of claim 1, wherein the first graft
comprises a laminated stent component.
36.-40. (canceled)
41. A stent graft system, comprising: a graft forming a lumen; at
least one support component embedded in the graft, each of the at
least one support component is a polymer ring surrounding the
graft, at least a portion of each of the at least one support
component is coupled to an external surface of the graft, the
external surface faces away from the lumen, wherein the at least
one support component comprises a first support component and a
second support component; the first support component is located on
a first end of the graft; and the second support component is
located on a second end of the graft.
42.-44. (canceled)
45. The stent graft system of claim 41, wherein the graft further
comprises inner sleeves or rings in the lumen that receive limb
grafts.
46. A system, comprising: a proximal extension inflatable fill
structure, configured to form a seal in a proximal neck region of
an aorta when the proximal extension inflatable fill structure is
inflated; and configured to form at least one lumen when the
proximal extension inflatable fill structure is inflated, wherein
in one or more of the at least one lumen is configured to receive a
limb stent graft; and a second graft; and a third graft, wherein
each of the first graft, the second graft, and the third graft are
separate grafts before being deployed forms and each comprises at
least one a single lumen; wherein the second graft and the third
graft are configured to be inserted into the lumen of the
inflatable fill structure when deployed, and when deployed, the
first graft, the second graft, and the third graft are coupled
together.
47. The system of claim 46, further comprising an anchor coupled to
the proximal extension inflatable fill structure.
48. The system of claim 46, wherein the proximal extension
inflatable fill structure forms a dual lumen.
49. The system of claim 46, wherein the second and third grafts are
placed in separate lumen in the proximal extension inflatable fill
structure.
50. (canceled)
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application claims priority from U.S. Provisional
Patent App. Ser. No. 62/735,771, filed Sep. 24, 2018, the entire
contents of which are incorporated by reference herein.
FIELD
[0002] The present technology relates generally to endoluminal
vascular prostheses and methods of placing/deploying such
prostheses. More particularly, various arrangements disclosed
herein relate to stent graft systems and to methods of
placing/deploying such stent graft systems for treating aortic
aneurysms.
BACKGROUND
[0003] Aneurysms are enlargements or bulges in blood vessels that
are often prone to rupture and which therefore present a serious
risk to a patient. Aneurysms may occur in any blood vessel but are
of particular concern when they occur in the cerebral vasculature
or the aorta.
[0004] Abdominal aortic aneurysms (AAAs) are classified based on
their locations within the aorta as well as their shapes and
complexity. Aneurysms that are found below the renal arteries are
referred to as infrarenal abdominal aortic aneurysms. Suprarenal
abdominal aortic aneurysms occur above the renal arteries. Thoracic
aortic aneurysms (TAAs) occur in the ascending, transverse, or
descending part of the upper aorta. Infrarenal aneurysms are the
most common, representing about 70% of all aortic aneurysms.
Suprarenal aneurysms are less common, representing about 20% of the
aortic aneurysms. TAAs are the least common and often the most
difficult to treat.
[0005] The most common form of aneurysm is "fusiform," where the
enlargement extends about the entire aortic circumference. Less
commonly, the aneurysms may be characterized by a bulge on one side
of the blood vessel attached at a narrow neck. TAAs are often
dissecting aneurysms caused by hemorrhagic separation in the aortic
wall, usually within the medial layer. A common treatment for each
of these types and forms of aneurysm is open surgical repair. Open
surgical repair is quite successful in patients who are otherwise
reasonably healthy and free from significant co-morbidities. Such
open surgical procedures are problematic, however, because access
to the abdominal and thoracic aortas is difficult to obtain, and
because the aorta must be clamped off, placing significant strain
on the patient's heart.
[0006] Endoluminal grafts have come into widespread use for the
treatment of aortic aneurysms in patients. A typical endograft
procedure utilizes a stent graft placement to treat the aneurysm.
The purpose of the graft is generally to isolate the diseased
portion of the aortic wall from the aortic blood pressure and
prevent further dilatation or rupture of the diseased portion of
the aortic wall. In general, endoluminal repairs access the
aneurysm "endoluminally" through either or both iliac arteries. The
grafts are then implanted. Successful endoluminal procedures have a
much shorter recovery period than open surgical procedures.
SUMMARY OF THE DISCLOSURE
[0007] Various stent graft systems and methods described herein are
directed to treating aneurysms. In some arrangements, a stent graft
system includes a first graft, a second graft, and a third graft.
Each of the first graft, the second graft, and the third graft
forms a single lumen. When deployed, the first graft, the second
graft, and the third graft are coupled together within an
aorta.
[0008] In some arrangements, the second graft and the third graft
are inserted into the single lumen of the first graft when
deployed. In some arrangements, a portion of the first graft is
placed in a proximal neck region of the aorta when deployed. A
portion of the second graft is placed in a first iliac artery of
the aorta when deployed. A portion of the third graft is placed in
a second iliac artery of the aorta when deployed.
[0009] In some arrangements, the first graft, the second graft, and
the third graft are separate grafts before being deployed. In some
arrangements, the stent graft system further includes an inflatable
fill structure at least partially surrounding the first graft. The
inflatable fill structure expands within the aorta when deployed. A
seal component coupled to the first graft. The seal component forms
a seal in a proximal neck region of the aorta.
[0010] In some arrangements, the seal component is filled to a
higher pressure than a pressure of the inflatable fill structure.
In some examples, the seal component and the inflatable fill
structure are filled using different channels. In some examples,
the inflatable fill structure, when deployed, at least partially
surrounds proximal ends of the second graft and the third graft
that are docked within the single lumen of the first graft. In some
examples, the inflatable fill structure is coupled to the first
graft. In some examples, the second graft and the third graft dock
within the single lumen of the first graft in a docking zone. The
inflatable fill structure, in an inflated state, surrounds at least
portions of the second graft and the third graft that are outside
of the docking zone. In some examples, the inflatable fill
structure is coupled to the first graft. The inflatable fill
structure, in an inflated state, surrounds portions of the second
graft and the third graft that are inside of iliac arteries when
deployed.
[0011] In some examples, the second graft and the third graft dock
within the single lumen of the first graft in a docking zone. The
first graft includes a support inflatable fill structure coupled to
a portion of the first graft in the docking zone. The support
inflatable fill structure is inflated to provide structural
integrity to the first graft. In some examples, the support
inflatable fill structure is inflated before or while the
inflatable fill structure is inflated. In some examples, the second
graft and the third graft dock within the single lumen of the first
graft in a docking zone. The first graft includes a wire-wound
stent component coupled to a portion of the first graft in the
docking zone. The wire-wound stent component includes a plurality
of wire-wound rings. In some examples, wherein the single lumen of
the first graft is open at the wire-wound stent component. In some
examples, the second graft and the third graft dock within the
single lumen of the first graft in a docking zone. The first graft
includes a wire-wound stent ring coupled to a portion of the first
graft in the docking zone, the wire-wound stent ring includes a
single ring of wire-wound stent.
[0012] In some examples, the inflatable fill structure is more
compliant than the seal component. In some examples, the inflatable
fill structure forms a funnel shape in an inflated state. In some
examples, the inflatable fill structure forms the funnel shape by
extending a portion of the inflatable fill structure adjacent to
walls of the aorta along the walls of the aorta farther than
another potion of the of the inflatable fill structure abutting and
adjacent to the first graft. In some examples, the inflatable fill
structure is a bifurcated inflatable fill structure that, when in
the inflated state, forms two lumens for receiving the second graft
and the third graft.
[0013] In some arrangements, the stent graft system further
includes a first inflatable fill structure at least partially
surrounding the first graft, a second inflatable fill structure at
least partially surrounding the second graft, and a third
inflatable fill structure at least partially surrounding the third
graft, the first inflatable fill structure, the second inflatable
fill structure, and the third inflatable fill structure are
separate inflatable fill structures that expand within the aorta
when deployed. In some examples, the first inflatable fill
structure expands into the single lumen of the first graft.
[0014] In some examples, the second inflatable fill structure
surrounds a portion but not all of an outer surface the second
graft. The third inflatable fill structure surrounds a portion but
not all of an outer surface the third graft. In some examples, the
second inflatable fill structure surrounds an entirety of an outer
surface the second graft. The third inflatable fill structure
surrounds an entirety of an outer surface the third graft.
[0015] In some arrangements, the stent graft system further
includes an inflatable fill structure coupled to the first graft.
The inflatable fill structure, while in an inflated state, forms a
seal in a proximal neck region of the aorta. The second graft and
the third graft dock within the single lumen of the first graft in
a docking zone. The inflatable fill structure, while in the
inflated state, surrounds at least portions of the second graft and
the third graft that are outside of the docking zone. The
inflatable fill structure, while in the inflated state, at least
partially surrounding the first graft.
[0016] In some arrangements, the stent graft system further
includes a first inflatable fill structure at least partially
surrounding the second graft and a second inflatable fill structure
at least partially surrounding the third graft. The first
inflatable fill structure and the second inflatable fill structure
expand within the aorta and surrounds at least partially the first
graft when deployed. In some examples, each of the second graft and
the third graft includes a wire-wound stent component. The
wire-wound stent component includes a plurality of wire-wound
rings. In some examples, the first inflatable fill structure and
the second inflatable fill structure are fixed to portions of the
second graft and the third graft that are inserted into the lumen
of the first graft. The first inflatable fill structure and the
second inflatable fill structure expand within the lumen of the
first graft. In some examples, the first inflatable fill structure
and the second inflatable fill structure expand into the lumen of
the first graft.
[0017] In some arrangements, the second graft and the third graft
dock within the single lumen of the first graft in a docking zone.
The first graft includes at least one support inflatable fill
structure coupled to a portion of the first graft in the docking
zone. The second graft and the third graft are inserted into an
opening of each of the at least one support inflatable fill
structure when the second graft and the third graft are inserted
into the single lumen of the first graft in the docking zone. The
at least one support inflatable fill structure provides a seal with
respect to the first graft, the second graft, and the third graft
within the lumen of the first graft. In some examples, the opening
has a bi-lobe shape.
[0018] In some arrangements, the second graft and the third graft
dock within the single lumen of the first graft in a docking zone.
The first graft includes at least one internal support component
coupled to a portion of the first graft in the docking zone. The
internal support component expands within the single lumen of the
first graft when inflated and forms a seal around the second graft
and the third graft when the second graft and the third graft are
inserted into the single lumen of the first graft in the docking
zone. In some arrangements, the first graft includes a seal
component coupled to a distal end of the first graft.
[0019] In some arrangements, the second graft and the third graft
dock within the single lumen of the first graft in a docking zone.
The first graft includes an internal inflatable fill structure
coupled to the first graft in the docking zone. The internal
inflatable fill structure expands within the single lumen of the
first graft when inflated and forms a seal around the second graft
and the third graft when the second graft and the third graft are
inserted into the single lumen of the first graft in the docking
zone. The internal inflatable fill structure forms a bifurcated
lumen.
[0020] In some examples, the bifurcated lumen is formed by
inflating a proximal portion of the internal inflatable fill
structure around a first balloon having a circular or oval cross
section and a distal portion of the internal inflatable fill
structure around a second balloon having a bi-lobe cross
section.
[0021] In some arrangements, the first graft includes a laminated
stent component. In some examples, the laminated stent component
includes Teflon-laminated nickel-titanium (NiTi)-stents.
[0022] In some arrangements, the stent graft system includes an
anchor configured to attach the first graft to the aorta. The
anchor includes hooks or barbs. In some arrangements, the anchor is
located on a stent ring of the first graft. In some arrangements,
the first graft includes a support structure coupled to the first
graft, the support structure being in the lumen of the first graft.
In some example, the support structure includes helix-shaped
polymer support rings.
[0023] In some arrangements, the stent graft system includes a
graft forming a lumen and at least one support component embedded
in the graft. Each of the at least one support component is a
polymer ring surrounding the graft. At least a portion of each of
the at least one support component is coupled to an external
surface of the graft, the external surface faces away from the
lumen. In some examples, the at least one support component
includes a first support component and a second support component.
The first support component is located on a first end of the graft.
The second support component is located on a second end of the
graft. In some examples, the at least one support component
includes three or more support components spaced apart from each
other along the graft. In some examples, the graft further forms a
bifurcated feature including two additional lumens that receive
limb stent grafts. In some examples, the graft further includes
inner sleeves or rings in the lumen that receive limb stent
grafts.
[0024] In some arrangements, a system includes a proximal extension
inflatable fill structure, the proximal extension inflatable fill
structure forms a seal in a proximal neck region of an aorta when
the proximal extension inflatable fill structure is inflated. The
system further includes at least one lumen formed by the proximal
extension inflatable fill structure when the proximal extension
inflatable fill structure is inflated. Each of the at least one
lumen receives a limb stent graft, the at least one lumen being
located in the proximal neck region when the proximal extension
inflatable fill structure forms the seal in the proximal neck
region. In some arrangements, the system further includes an anchor
coupled to the proximal extension inflatable fill structure. In
some examples, a length of the anchor is 30 mm. In some examples, a
width of the proximal extension inflatable fill structure when
filled is 20 mm. In some examples, the proximal extension
inflatable fill structure is an endobag.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] FIG. 1 is a cross-sectional view of an example infrarenal
aortic aneurysm of a patient.
[0026] FIG. 2 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0027] FIG. 3A is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements. FIG. 3B is another cross-sectional view of the
example stent graft system (FIG. 3A) deployed across an aneurysm
according to various arrangements.
[0028] FIG. 4A is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements. FIG. 4B is another cross-sectional view of the
example stent graft system (FIG. 4A) deployed across an aneurysm
according to various arrangements.
[0029] FIG. 5 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0030] FIG. 6A is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements. FIG. 6B is another cross-sectional view of the
example stent graft system (FIG. 6A) deployed across an aneurysm
according to various arrangements.
[0031] FIG. 7 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0032] FIG. 8 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0033] FIG. 9 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0034] FIG. 10 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0035] FIG. 11A is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements. FIG. 11B is another cross-sectional view of the
example stent graft system (FIG. 11A) deployed across an aneurysm
according to various arrangements.
[0036] FIG. 12 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0037] FIG. 13A is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements. FIG. 13B is another cross-sectional view of the
example stent graft system (FIG. 13A) deployed across an aneurysm
according to various arrangements.
[0038] FIG. 14 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0039] FIG. 15A is a cross-sectional view of an example stent graft
system deployed across the aneurysm (FIG. 1) according to various
arrangements. FIG. 15B is another cross-sectional view of the
example stent graft system (FIG. 15A) deployed across the aneurysm
(FIG. 1) according to various arrangements. FIG. 15C is yet another
cross-sectional view of the example stent graft system (FIG. 15A)
deployed across the aneurysm (FIG. 1) according to various
arrangements.
[0040] FIG. 16 is a cross-sectional view of an example stent graft
system deployed across an aneurysm according to various
arrangements.
[0041] FIG. 17 is a cross-sectional view of an example stent graft
system deployed across the aneurysm 14 (FIG. 1) according to
various arrangements.
[0042] FIG. 18 is a cross-sectional view of an example stent graft
system deployed across the aneurysm 14 (FIG. 1) according to
various arrangements.
[0043] FIG. 19 is a cross-sectional view of an example stent graft
system deployed across the aneurysm 14 (FIG. 1) according to
various arrangements.
[0044] FIGS. 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I, 20J, 20K,
and 20L illustrate examples of a proximal graft according to
various arrangements.
[0045] FIGS. 21A, 21B, 21C, and 21D illustrate examples of a stent
graft according to various arrangements.
[0046] FIG. 22A illustrates an example proximal extension
inflatable fill structure of a stent graft system according to
various arrangements.
[0047] FIG. 22B is a cross-sectional view of the stent graft system
(FIG. 22A) deployed across the aneurysm 14 (FIG. 1) according to
various arrangements.
[0048] FIG. 23 illustrate an example proximal extension inflatable
structure of a stent graft system according to various
arrangements.
DETAILED DESCRIPTION
[0049] Various arrangements are described hereinafter. It should be
noted that the specific arrangements are not intended as an
exhaustive description or as a limitation to the broader aspects
discussed herein. One aspect described in conjunction with a
particular arrangement is not necessarily limited to that
arrangement and may be practiced with any other arrangement(s).
[0050] Various arrangements disclosed herein relate to a stent
graft system that includes a single-lumen proximal graft coupled to
an inflatable fill structure (e.g., an endobag) and limb stent
grafts (limbs) that may be coupled to one or more inflatable fill
structures. Such a stent graft system includes one or more
additional inflatable fill structures (e.g., those coupled to the
limbs) for sac management. Sac management refers to the management
of support in the aneurysm sac. An anchor (e.g., a component of the
stent graft system used for fixing or attaching the stent graft
system to the aorta) is separate from a seal component and separate
from the sac management component (e.g., the inflatable fill
structures), resulting in a more robust design as compared to the
designs of other stent graft systems. In some implementations, the
seal component coupled to the proximal graft is sized appropriately
(e.g., by including a wide seal ring), which improves placement
accuracy. In some implementations, the stent graft system includes
a large single-lumen proximal graft (e.g., having a large bore
diameter), which is easier to cannulate than other devices (e.g.,
stent graft systems having a graft component with a bifurcated
lumen) and thus needs less procedure time and fluoro time as
compared to the other devices. Various arrangements of the stent
graft systems are cheaper to manufacture as compared to other
devices (e.g., the devices having a graft component with a
bifurcated lumen) because the single-lumen proximal graft is
cheaper to manufacture than a graft with a bifurcated lumen.
[0051] Various arrangements disclosed herein relate to a stent
graft system that includes a proximal graft having a proximal
suprarenal self-expanding stent with fixation features coupled to a
dual-lumen polymer filled inflatable fill structure (e.g., a
dual-lumen polymer filled endobag). As compared to current AAA
devices, the disclosed stent graft systems include a custom neck
sealing and proximal fixation to the sac management feature of
stent graft systems. For example, the disclosed stent graft systems
separate proximal fixation, neck seal, cuff-to-stent-graft seal,
and stent-graft-to-sac seal. Furthermore, the seal component (e.g.,
the cuff) of such a stent graft system is sized appropriately by
having a wide sealing area below a fixation feature (e.g., the
fixation stent frame), thus improving placement accuracy. In some
implementations, a separate neck seal (e.g., a custom neck seal)
can produce higher sealing pressures than the sealing pressures of
seals of other stent graft systems, which allows the neck seal to
last longer.
[0052] In some cases, the more design requirements or
functionalities are placed on a design feature (e.g., a discrete,
separate component) of a stent graft system, the less efficient the
design feature can become. Various arrangements of the stent graft
system as described herein include separate design features or
components for fixation, sealing, and sac management.
[0053] Some arrangements of the stent graft system include a
proximal graft that is single-lumen, referred to herein as a
single-lumen proximal graft. The single-lumen proximal graft has a
bore diameter and an overall length similar to a diameter and
overall length of an aortic body. A single-lumen proximal graft is
less complex as a structure/component and is easier to manufacture
than a bifurcated lumen. An unsupported portion of the single-lumen
proximal graft has a sufficient length (e.g., approximately 30 mm)
that is above limb edges (that are inside the single-lumen proximal
graft) for bailout procedures (e.g., deploying a Palmaz stent
inside single-lumen proximal graft) or to build up from the stent
graft system to treat complex AAAs and TAAs.
[0054] In some arrangements, the proximal graft includes a
suprarenal laser-cut stent with coils attached thereon. In some
examples, the suprarenal stent has a stent shorter than that of
some current stent graft systems to eliminate free crowns. A
shorter stent allows for a larger neck angle indication due to an
improved stent graft flexibility. As such, the suprarenal stent in
the stent graft systems described herein is shorter and has fewer
crowns and fewer anchor, which allows the stent graft systems to be
used for smaller treatment sizes. That is, the stent graft systems
described herein is a low-profile delivery system used for small
treatment sizes.
[0055] In some arrangements, the seal component includes a
polytetrafluoroethylene (PTFE) polymer seal ring that is wider as
compared to the seal rings on other devices. A wider seal ring
improves placement accuracy given that even if the stent graft
system is placed lower (e.g., 1 mm lower) than an optimal position,
the wider seal ring can nevertheless provide a tight seal in a neck
of an aorta. Furthermore, the wider seal ring has a wider treatment
diameter range, which means fewer number of seal ring sizes (and
fewer number of stock keeping unit (SKUs)) are needed for treating
the entire vessel treatment range. In some arrangements, a neck
length of the aortic neck region in which the seal component is
configured to be deployed can be shorter than the neck lengths in
which the seal components of other devices are configured to be
deployed. Furthermore, the wide seal ring can improve the neck
angle indication.
[0056] In some arrangements, the proximal graft includes an
inflatable fill structure (e.g., an endobag) attached thereto. For
sac management, the inflatable fill structure is deployed at a
location below (in the distal direction of) the seal component. The
inflatable fill structure can include a dedicated fill port through
which the inflatable fill structure is filled or inflated, in some
examples. In other examples, the inflatable fill structure and the
seal component are filled using a same fill port, thus reducing the
delivery system profile.
[0057] In some examples, the inflatable fill structure can be made
from PTFE or a low-durometer polyurethane. In some cases, PTFE is
used for the inflatable fill structure given that PTFE can be
thermally bonded to the PTFE bore of the proximal graft and/or the
PTFE bore of the seal component. In some examples in which the
inflatable fill structure is made from PTFE, a larger inflatable
fill structure is implemented given that PTFE is less elastic,
where such a large inflatable fill structure can increase the
device profile. On the other hand, in some examples in which the
inflatable fill structure is made from polyurethane, less material
is needed for the inflatable fill structure than the materials
needed for an inflatable fill structure made from PTFE given that
polyurethane is more elastic than PTFE, where less material can
reduce the device profile. However, polyurethane cannot be
thermally bonded to the PTFE proximal graft and/or the PTFE seal
component easily. Thus, if polyurethane is used for the inflatable
fill structure, the polyurethane of the inflatable fill structure
is sutured to the PTFE proximal graft and/or the PTFE seal
component. In some cases, blood can enter a space between the bore
of the proximal graft and an inner lumen of the inflatable fill
structure, thus pressurizing the inner lumen.
[0058] With respect to docking, a distal proximal graft section in
which limbs dock has a universal bore size for all proximal graft
sizes, such that the proximal graft can taper in or out to a
desired vessel size. In various arrangements, the proximal graft is
supported by a wire-wound stent to avoid kinking the proximal graft
lumen in angulated anatomy. In some arrangements, a distal proximal
graft universal docking section is supported by a wire-wound stent
for docking the limbs with sufficient radial force to minimize the
likelihood of dislodgement between the proximal graft and the
limbs, so as to minimize Type III Endoleaks. With respect to an
unsupported proximal graft, another inflatable fill structure
(e.g., a balloon placed inside of the proximal graft) can be used
as the inflatable fill structure (e.g., the endobag) is being
filled to avoid proximal graft collapsing. In some examples, the
balloon can be integrated with the proximal graft delivery system.
That is, the balloon can be filled using the catheter used to fill
the proximal graft. Alternatively, the balloon can be filled using
a catheter separate from the catheter used for the proximal graft
delivery system.
[0059] In some arrangements, limbs described herein can be
self-expanding PTFE-covered stents or balloon-expandable
PTFE-covered stents. The self-expanding PTFE-covered stents have
sufficient radial structural integrity (e.g., radial force) to
prevent lumen collapse during as the inflatable fill structure
(e.g., the endobag) is being filled. On the other hand, the
balloon-expandable PTFE-covered stents need a balloon to expand the
stent. As such, the self-expanding PTFE-covered stents have a
smaller device profile as compared to the device profile of the
balloon-expandable PTFE-covered stents.
[0060] With respect to fixation (e.g., docking, deployment,
insertion, and so on) in which the proximal graft is coupled to the
limbs, in some arrangements, the limb diameters of at least one
limb docked or to be docked in a docking zone (or an overlap zone)
is smaller than a diameter of the bore of the proximal graft. In
such examples, the inflatable structure (e.g., the endobag) around
each limb inside the docking zone can seal off gutters that are
typically present when docking the at least one limb inside a
larger bore. In alternative arrangements, the sum of limb diameters
of the at least one limb docked or to be docked in the docking zone
is greater than the diameter of the proximal graft bore. In the
example in which two limbs are docked into the docking zone, the
cross sections of the two limbs are compressed into D-shapes inside
the proximal graft bore, creating joint separation resistance due
to radial force exerted by the limbs against the proximal graft
bore. In such arrangements, the limbs can each include an
inflatable fill structure (e.g., an endobag) in the docking zone to
seal off any remaining gutters.
[0061] With respect to sac management, in various arrangements, the
limbs have inflatable fill structures (e.g., endobags) attached to
PTFE-covered stents of the limbs. The inflatable fill structure can
cover an entire length of a limb, including part of the limb that
is in the docking zone of the proximal graft. The inflatable fill
structure can seal off the aneurysm sac and create a seal in the
distal iliacs. In some arrangements, the inflatable fill structures
for the proximal graft and/or the limbs may be optional, depending
on whether a type II Endoleak is present.
[0062] FIG. 1 is a cross-sectional view of an example infrarenal
aortic aneurysm 14 of a patient. Referring to FIG. 1, an aorta 10
branches at an aortic bifurcation 11 into two iliac arteries 12 and
13. A sac of the aneurysm 14 corresponds to a bulged section of the
aorta 10. The infrarenal aortic aneurysm 14 is located below (in a
distal direction relative to) renal arteries 15 and 16. A segment
of the aorta 10 between the renal arteries 15 and 16 and the sac of
the aneurysm 14 is referred to as a proximal neck region 17. The
proximal neck region 17 has a diameter 83 that is different for
different patients. Often, a mural thrombus 18 forms on an inside
wall of the sac of the aneurysm 14. The mural thrombus 18 may be
omitted in other Figures for clarity.
[0063] With reference to FIG. 1, the dimensions of the aneurysm 14
can vary greatly from patient to patient. The diameter of the
proximal neck region 17 may vary, for example, from 18 mm to 34 mm.
The distance from the aortic bifurcation 11 to the renal arteries
15 and 16 may vary, for example, from 80 mm to 160 mm. The
diameters of the right and left iliac arteries 12 and 13 may not be
the same. The diameters of the iliac arteries 12 and 13 at the
aortic bifurcation 11 may vary, for example, from 8 mm to 20 mm.
One or both of the iliac arteries 12 and 13 may be aneurysmal with
greatly enlarged diameters, for example, of more than 30 mm.
[0064] FIG. 2 is a cross-sectional view of an example stent graft
system 200 deployed across the aneurysm 14 (FIG. 1), according to
various arrangements. Referring to FIGS. 1 and 2, the stent graft
system 200 is an endovascular graft system, an infrarenal
prosthesis, and so on. The stent graft system 200 includes a
proximal graft 212, a first limb stent graft 214a, a second limb
stent graft 214b, an inflatable fill structure 230, a seal
component 240, and an anchor 245.
[0065] In some arrangements, the proximal graft 212 can be a graft
component made from a graft material without stents in some
examples. The proximal graft 212 has a proximal end, a distal end,
and an external surface. The proximal end of the proximal graft 212
is the end of the proximal graft 212 that is closer to or in the
proximal neck region 17 when deployed. As shown, the proximal end
of the proximal graft 212 can be placed in the proximal neck region
17 when deployed. The distal end of the proximal graft 212 is the
end of the proximal graft 212 that is closer to the aortic
bifurcation 11 when deployed. As shown, the distal end of the
proximal graft 212 can be placed into the sac of the aneurysm 14,
which is between the proximal neck region 17 and the aortic
bifurcation 11. The external surface of the proximal graft 212
faces walls/surfaces of the aorta 10 and faces away from a tubular
lumen of the proximal graft 212.
[0066] In some arrangements, the limb stent grafts 214a and 214b
can be referred to as limbs. In some examples, each of the limb
stent grafts described herein (e.g., the limb stent grafts 214a and
214b) includes graft material with stents. In other examples, a
limb stent graft may be simply graft material without stents. Each
of the limb stent grafts 214a and 214b can be a self-expanding
PTFE-covered stent or a balloon-expandable PTFE-covered stent. Each
of the first limb stent graft 214a and the second limb stent graft
214b has a proximal end, a distal end, and an external surface. The
proximal end of each of the limb stent grafts 214a and 214b is an
end of each of the limb stent grafts 214a and 214b that is closer
to the proximal neck region 17 when deployed. As shown, the
proximal ends of the limb stent grafts 214a and 214b can be placed
in the sac of the aneurysm 14. The distal end of each of the limb
stent grafts 214a and 214b is an end of each of the limb stent
grafts 214a and 214b that is closer to or in the iliac arteries 12
and 13. As shown, the distal end of the first limb stent graft 214a
can be placed in the iliac artery 12 when deployed, and the distal
end of the second limb stent graft 214b can be placed in the iliac
artery 13 when deployed. The limb stent grafts 214a and 214b can be
placed at or adjacent to the aortic bifurcation 11. The external
surface of each of the limb stent grafts 214a and 214b faces the
walls/surfaces of the aorta 10 and faces away from a tubular lumen
of each of the limb stent grafts 214a and 214b.
[0067] The stent graft system 200 can be deployed across the
aneurysm 14 in any suitable manner. In one example, the distal ends
of limb stent grafts 214a and 214b are first placed into the iliac
arteries 12 and 13, respectively. The distal end of the proximal
graft 212 is then placed over and around the proximal ends of the
limb stent grafts 214a and 214b, such that the proximal ends of the
limb stent grafts 214a and 214b are inserted into the tubular lumen
of the distal end of the proximal graft 212. The portions of the
limb stent grafts 214a and 214b that are inserted into the proximal
graft 212 and the portion of the proximal graft 212 that surrounds
the limb stent grafts 214a and 214b are in a docking zone 250 (an
overlap zone or a distal proximal graft universal docking section
in which the proximal graft 212 and the limb stent grafts 214a and
214b overlap). When the distal end of the proximal graft 212 is
placed over the limb stent grafts 214a and 214b, the proximal end
of the proximal graft 212 is placed in the proximal neck region 17.
In this manner, the proximal graft 212 can extend aneurysm repair
into the proximal neck region 17.
[0068] In some examples, the inflatable fill structure 230 can be
made from PTFE, a low-durometer polyurethane, or so on. In some
cases, PTFE is used for the inflatable fill structure 230 given
that PTFE can be thermally bonded to the PTFE bore of the proximal
graft 212 and/or the PTFE bore of the seal component 240. In some
examples in which the inflatable fill structure 230 is made from
PTFE, a larger inflatable fill structure 230 can implemented given
that PTFE is less elastic, where such a large inflatable fill
structure 230 can increase the device profile. On the other hand,
in some examples in which the inflatable fill structure 230 is made
from polyurethane, less material is needed as compared to the
materials needed for the inflatable fill structure 230 made from
PTFE given that polyurethane is more elastic than PTFE. Less
material can reduce the device profile. However, polyurethane
cannot be thermally bonded to the PTFE proximal graft 212 easily.
Thus, if polyurethane is used for the inflatable fill structure
230, the polyurethane of the inflatable fill structure 230 is
sutured to the PTFE proximal graft 212. In some cases, blood can
enter a space between the bore of the proximal graft 212 and an
inner lumen of the inflatable fill structure 230, thus pressurizing
the inner lumen.
[0069] The inflatable fill structure 230 is fillable with a fill
medium using an inflatable channel, a fill structure, or a fill
line. Examples of the fill medium include but are not limited to,
polyesters, PTFE, polyurethane, and so on. When the inflatable fill
structure 230 is filled with the fill medium to the fullest, the
inflatable fill structure 230 is in a filled or inflated state.
When the inflatable fill structure 230 is not filled with any fill
medium, the inflatable fill structure 230 is in an unfilled or
uninflated state. The inflatable fill structure 230 surrounds at
least a portion the proximal graft 212 in the inflated state. As
shown, when deployed, the inflatable fill structure 230 (in the
inflated state) surrounds the portion of the proximal graft 212
that is inside of the sac of the aneurysm 14 and between a lower
boundary of the proximal neck region 17 and the aortic bifurcation
11. The inflatable fill structure 230 (in the inflated state) does
not surround any portion of the proximal graft 212 that is inside
of the proximal neck region 17. For sac management, the inflatable
fill structure 230 is deployed to a location below (in the distal
direction of) the seal component 240. The inflatable fill structure
230 surrounds at least the distal end of the proximal graft 212 in
the inflated state. In various examples, the inflatable fill
structure 230 is an endobag fixed to a portion of the external
surface of proximal graft 212 and includes an outer membrane that
does not extend beyond the distal end of the proximal graft 212
when the inflatable fill structure 230 is in the inflated state. In
other words, the inflatable fill structure 230 (in the inflated
state) does not surround any portion of the limb stent grafts 214a
and 214b that is not inserted into the proximal graft 212 when the
stent graft system 200 is deployed.
[0070] The inflatable fill structure 230 is fixed to the portion of
the external surface of proximal graft 212 and is initially in the
uninflated state when the proximal graft 212 is placed over the
limb stent grafts 214a and 214b. Next, the inflatable fill
structure 230 is filled with the fill medium to achieve the
inflated state. A portion of the inflatable fill structure 230
extends and expands radially into a space the sac of the aneurysm
14 that is adjacent to the proximal graft 212 when the inflatable
fill structure 230 is being filled. When in the uninflated state,
the inflatable fill structure 230 can be confined to being around
the proximal graft 212, and when in the inflated state as shown,
the inflatable fill structure 230 expands radially and proximally
to fill the entire (or most of the) aneurysm 14 that is between the
distal end of the proximal graft 212 and the lower boundary of the
proximal neck region 17. The fill medium pushes a wall (e.g., the
outer membrane) of the inflatable fill structure 230 against the
walls/surfaces of the aneurysm 14 when the inflatable fill
structure 230 is in the filled state. When the inflatable fill
structure 230 is in the filled state, the inflatable fill structure
230 can conform to the walls/surfaces of the aneurysm 14 and a
portion of the outer surface of the proximal graft 212.
[0071] The proximal graft 212 and the limb stent grafts 214a and
214b are separate grafts (before deployment) that are connected,
joined, or otherwise joined coupled when deployed in the manner
described. Each of the proximal graft 212 and the limb stent grafts
214a and 214b is a single-lumen graft. A single-lumen graft is less
complex as a structure/component and is easier and cheaper to
manufacture than a bifurcated-lumen graft. In some implementations,
the proximal graft 212 has a large bore diameter, which is easier
to cannulate than other devices with a graft having a bifurcated
lumen and thus needs less procedure time and fluoro time as
compared to such other devices. The single-lumen proximal graft 212
has a bore diameter and an overall length similar to a diameter and
overall length of the aorta 10, respectively. An unsupported
portion of the single-lumen proximal graft 212 refers to the
portion of the single-lumen proximal graft 212 that has the graft
material (e.g., the PTFE) without stent for structural support. The
unsupported portion of the single-lumen proximal graft 212 (outside
of the docking zone 250 and above and in the proximal direction of
the proximal edges/ends of the limb stent grafts 214a and 214b that
are inside the single-lumen proximal graft 212 when deployed in the
manner described) has a sufficient length (e.g., approximately 30
mm) for bailout procedures (such as but not limited to, deploying a
Palmaz stent inside single-lumen proximal graft) or for building up
from the stent graft system 200 to treat complex AAAs and TAAs.
[0072] In various arrangements, the anchor 245 (a fixation feature,
a fixation stent frame, and so on) anchors, fixes, or attaches the
proximal end of the stent graft system 200 (e.g., the proximal
graft 212) to the walls/surfaces of the aorta 10, prevents
intrusion of blood into a region between an outer wall and an inner
surface of the aneurysm 14, and improves the transition from the
aorta 10 into the tubular lumen of the proximal graft 212. In some
examples, the anchor 245 can include a stent, graft, and/or other
expandable luminal support structure. In some examples, the anchor
245 includes a suprarenal laser-cut stent with coils attached
thereon. In some examples, the anchor 245 has a stent shorter than
that of some current stent graft systems to eliminate free crowns.
A shorter stent allows for a larger neck angle indication due to an
improved stent graft flexibility. As such, the suprarenal stent of
the anchor 245 is shorter and has fewer crowns and fewer anchors,
allowing the stent graft systems 200 to be used for smaller
treatment sizes. That is, the stent graft system 200 is a
low-profile delivery system that can be used for small treatment
sizes.
[0073] In some examples, the anchor 245 is a stent-like scaffold
structure that can be implanted in an upper proximal opening of a
tubular lumen or end of the proximal end of the proximal graft 212.
As shown, the anchor 245 extends from the proximal end of the
proximal graft 212 in the proximal direction. When deployed, the
anchor 245 can extend from a position inside or on a boundary of
the proximal neck region 17 and over the openings to the renal
arteries 15 and 16 (e.g., the renal ostia). The anchor 245 includes
hooks or barbs that anchor, fix, or attach to the walls/surfaces of
the aorta 10 that are proximal relative to the renal ostia and the
proximal neck region 17. The anchor 245 includes openings or ports
to allow penetrating blood flow into the renal arteries 15 and 16.
As shown, given that the anchor 245 has a stent-like scaffold
structure, blood can flow into the renal arteries 15 and 16 through
the renal ostia unobstructed.
[0074] Each of the grafts 212, 214a, and 214b can include one or
more fill lines or inflatable channels through which hardenable
inflation materials or fill polymers are communicated in liquid
form. In some arrangements, each of the grafts 212, 214a, and 214b
can include one or more circumferential inflatable channels
extending around a circumference of a graft body of each of the
grafts 212, 214a, and 214b or that may extend partially around the
circumference of the graft body of each of the grafts 212, 214a,
and 214b. In some implementations, the inflatable channels can be
in fluid communication with each other via a longitudinal
inflatable fill channel in the graft body. The network of
inflatable channels can be filled with a hardenable material that
hardens, cures or otherwise increases in viscosity or becomes more
rigid after being injected into the channels. Hardenable inflation
materials such as gels, liquids or other flowable materials that
are curable to a more solid or substantially hardened state may be
used to provide mechanical support to the graft body of each of the
grafts 212, 214a, and 214b by virtue of the mechanical properties
of the hardened material disposed within the channels. In some
arrangements, the filling agent is saline. In some arrangements,
the filling agent is a gas.
[0075] In some implementations, the seal component 240 (e.g., a
cuff, a separate neck seal, a custom neck seal, and so on) can be
an inflatable seal ring. The seal component 240 accommodates
varying sizes of the aorta 10, for example, especially the varying
sizes of the proximal neck region 17. In some examples and as shown
in FIG. 2, the seal component 240 continuously contact an inner
wall of the proximal neck region 17 to provide continuous sealing
at the proximal neck region 17 while in the inflated state.
Continuously contacting the inner wall of the proximal neck region
17 refers to the fact that the seal component 240, when in the
inflated state, sufficiently contacts the inner wall to form a
fluid seal therewith, or contacts the entire inner wall
continuously, without any portion of the seal component 240 not
contacting the inner wall of the proximal neck region 17.
[0076] In some implementations, the seal component 240 is coupled
to the proximal graft 212. For example, the seal component 240 is
attached, fixed, or otherwise coupled to the outer surface of the
proximal graft 212. In the inflated state, the seal component 240
surrounds the portion of the proximal graft 212 that is in the
proximal neck region 17 when the proximal graft 212 is deployed.
The seal component 240 is located at or near the proximal end of
the proximal graft 212. In some example, when the seal component
240 is in the inflated state, the seal component 240 does not reach
and does not extend past the edge of the proximal end of the
proximal graft 212 such that a portion of the proximal graft 212
adjacent to the edge of the proximal end of the proximal graft 212
is not surrounded by the seal component 240. In other examples,
when the seal component 240 is in the inflated state, the seal
component 240 reaches or extends past the edge of the proximal end
of the proximal graft 212.
[0077] The graft materials used for the stent graft system 200
include but are not limited to, polyesters, PTFE, polyurethane, and
the like. In some arrangements, each of the grafts 212, 214a, and
214b is a stent covered in the graft materials. In some
arrangements the seal component 240 has or is in communication with
a fill line or an inflatable channel through which hardenable
inflation materials or fill polymers (e.g., polyesters, PTFE,
polyurethane, and the like) are communicated in liquid form.
[0078] In some examples, the seal component 240 uses an inflatable
channel and a fill port different from the inflatable channels and
fill ports used by the rest of the stent graft system 200. That is,
the seal component 240 does not share an inflatable channel or fill
port with other components (e.g., the grafts 212, 214a, and 214b,
the inflatable fill structure 230, and so on). As such, when
deploying the stent graft system 200, at least a first inflatable
channel coupled to the inflatable fill structure 230 and a first
fill port on the inflatable fill structure 230 are used to inject
fill polymers to the inflatable fill structure 230, and a second
inflatable channel coupled to the seal component 240 and a second
fill port of the seal component 240 are used to inject fill
polymers to the seal component 240.
[0079] In some examples in which the seal component 240 is inflated
using a dedicated inflatable channel that is not shared with
another component (e.g., the inflatable fill structure 230) of the
stent graft system 200, the seal component 240 can be inflated
(using the dedicated inflatable channel) to and using a pressure
higher than, for example, the pressure to which the inflatable fill
structure 230 is filled using the inflatable channel of the
inflatable fill structure 230. In some examples, the inflatable
fill structure 230 is inflated to and using a lower pressure (e.g.,
approximately 120-180 mmHg), which may not be sufficient to
adequately inflate the seal component 240. As the seal component
240 is filled to and using a higher pressure (e.g., 180 mm Hg-760
mm Hg), the seal component 240 can prevent the inflatable fill
structure 230 from prolapsing into the renal arteries 15 and 16
when the inflatable fill structure 230 is being inflated. In that
case, the seal component 240 is inflated before the inflatable fill
structure 230 is inflated. The seal component 240, which is filled
to a higher pressure to form the seal at the proximal neck region
17, functions like a stopper that prevents the inflatable fill
structure 230 from prolapsing into the renal arteries 15 and 16
through the proximal neck region 17. Furthermore, the seal
component 240 can be filled at a higher pressure because the seal
component 240 is contacting healthy tissue, which is capable of
handling a higher pressure for sealing and anchoring purposes. The
inflatable fill structure 230 on the other hand contacts the
aneurysm sac (unhealthy tissue), and therefore should be filled at
a lower pressure.
[0080] In other examples, the seal component 240 can use an
inflatable channel and a fill port that is also used by another
component (e.g., the inflatable fill structure 230 of the stent
graft system 200). That is, the seal component 240 shares an
inflatable channel and a fill port with another component (e.g.,
the inflatable fill structure 230, and so on) of the stent graft
system 200. Device profile and delivery system profile can be
reduced if the inflatable channel and the fill port are shared.
[0081] In some arrangements, the seal component 240 is a wide PTFE
polymer seal ring. The PTFE polymer seal ring of the seal component
240 is wider as compared to the seal rings on other devices. In one
example, the seal component 240, in the inflated state and deployed
entirely in the proximal neck region 17, is at least 10 mm wide
along the longitudinal dimension of the aorta 10 (e.g., in the
proximal distal directions). The wider seal ring improves placement
accuracy given that even if the stent graft system 200 (e.g., the
proximal graft 212 and the seal component 240) is placed lower
(e.g., 1 mm lower) than an optimal position, the wider seal ring of
the seal component 240 can nevertheless provide a sufficiently
tight seal in the proximal neck region 17. The optimal position
corresponds to a position of the stent graft system 200 that allows
the seal component 240 (in the inflated state) to be entirely
within the proximal neck region 17 (and not in the sac of the
aneurysm 14) when the stent graft system 200 is deployed in the
manner described. Given that the width/radius of the sac of the
aneurysm 14 is larger than the width/radius of the proximal neck
region 17, the portion of the seal component 240 that is outside of
the proximal neck region 17 and inside of the sac of the aneurysm
14 may not form a tight seal relative to the wall of the sac. As
the seal component 240 includes the wide seal ring, although the
part of the seal component 240 that is outside of the proximal neck
region 17 and inside of the sac of the aneurysm 14 may not form a
tight seal, most of the seal component 240 is still inside of the
proximal neck region 17 even if the stent graft system 200 (e.g.,
the proximal graft 212 and the seal component 240) is placed lower
than the optimal position. The portion of the seal component 240
that is inside of the proximal neck region 17 can still provide a
sufficiently tight seal. As such, even if the stent graft system
200 is placed lower than the optimal position, the placement can
nevertheless be considered to be accurate because the seal
component 240 can still provide the sufficiently tight seal.
[0082] Furthermore, the wider seal ring of the seal component 240
has a wider treatment diameter range. As such, a fewer number of
different treatment diameter ranges of the wider seal ring are
needed. This means that a fewer number of seal ring sizes and a
fewer number of SKUs corresponding to those seal right sizes are
needed for treating the entire vessel treatment range (e.g., to
accommodate patients with different sizes of the proximal neck
region 17). In one example, as soon as the seal component 240
expands radially (while being filled) to a point that the seal
component 240 contacts the inner wall of the proximal neck region
17, the seal component 240 then expands longitudinally in the
proximal neck region 17. This allows the seal component 240 to be
applied to a larger range of blood vessel sizes. Thus, fewer sizes
for the seal component 240 need to be manufactured, and flexibility
and cost are improved. Furthermore, the wide seal ring can improve
the neck angle indication.
[0083] As shown, the anchor 245 (for fixation or attachment to the
aorta 10), the seal component 240 (for sealing the proximal neck
region 17), and the inflatable fill structure 230 (for sac
management) are separate components. That is, each of the anchor
245, the seal component 240, and the inflatable fill structure 230
has a single respective function, which results in a more robust
design as compared to the designs of other stent graft systems.
[0084] FIG. 3A is a cross-sectional view of an example stent graft
system 300 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 3B is another cross-sectional view of
the example stent graft system 300 (FIG. 3A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. Referring
to FIGS. 1-3B, the stent graft system 300 includes the proximal
graft 212, the first limb stent graft 214a, the second limb stent
graft 214b, an inflatable fill structure 330, the seal component
240, and the anchor 245. The proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, and the anchor 245 are components of the stent graft
system 300 that are similar to and confer similar improvements as
the corresponding components of the stent graft system 200. In
addition, as deployed in the aorta 10, the first limb stent graft
214a and the second limb stent graft 214b can be docked in the
proximal graft 212 (e.g., in the docking zone 250) in the manner
described. As shown, FIG. 3B is the cross-sectional view of the
stent graft system 300 that is cut away in the docking zone 250 as
shown in FIG. 3A.
[0085] In some examples, a limb diameter of the first limb stent
graft 214a and a limb diameter the second limb stent graft 214b (in
the docking zone 250) are substantially less than a diameter of the
bore of the lumen of the proximal graft 212. In such examples,
gutters 302 are typically present in the docking zone 250 as the
limb stent grafts 214a and 214b are docked into the larger bore of
the proximal graft 212. The inflatable fill structure 330 is shaped
to seal off such gutters 302. The inflatable fill structure 330 is
similar to the inflatable fill structure 230, except that the
inflatable fill structure 330 is shaped to extend into the sac of
the aneurysm 14 and surround each of the limb stent grafts 214a and
214b (including portions of the limb stent grafts 214a and 214b
that are outside of the docking zone 250) when deployed. The
inflatable fill structure 330 is filled by the fill line 301 after
the limb stent grafts 214a and 214b are docked inside of the single
lumen of the proximal graft 212. As shown, as being filled to the
inflated state, the inflatable fill structure 330, which is fixed,
bonded, attached, or otherwise coupled to the external surface of
the proximal graft 212, can extend in the distal direction toward
the iliac arteries 12 and 13 and the aortic bifurcation 11 to
surround the limb stent grafts 214a and 214b while pushing against
the surfaces/walls of the sac of the aneurysm 14 radially. The limb
stent grafts 214a and 214b do not have any inflatable fill
structure fixed, bonded, attached, or otherwise coupled.
Accordingly, the inflatable fill structure 330 can close off the
gutters 302 (by virtue of surrounding the limb stent grafts 214a
and 214b) and fill the aneurysm sac from the proximal neck region
17 to aortic bifurcation 11. In some examples (not shown), the
inflatable fill structure 330 can even extend into the iliac
arteries 12 and 13 while surrounding the portions of the limb stent
grafts 214a and 214b that are inside of the iliac arteries 12 and
13. As such, to seal the entire sac of the aneurysm 14, including
the gutters 302, and sometimes even the iliac arteries 12 and 13,
only one component (the inflatable fill structure 330) is needed,
and only one fill line (the fill line 301) and one fill operation
is needed, resulting in a shorter procedural time. Given that the
limb stent grafts 214a and 214b do not have any inflatable fill
structures, costs of the stent graft system 300 is also lower.
[0086] FIG. 4A is a cross-sectional view of an example stent graft
system 400 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 4B is another cross-sectional view of
the example stent graft system 400 (FIG. 4A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. Referring
to FIGS. 1, 2, and 4A-4B, the stent graft system 400 includes the
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, inflatable fill structures 430, 432, and
434, and the anchor 245. The proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, and the anchor
245 are components of the stent graft system 400 that are similar
to and confer similar improvements as the corresponding components
of the stent graft system 200. In addition, as deployed in the
aorta 10, the first limb stent graft 214a and the second limb stent
graft 214b can be docked in the proximal graft 212 (e.g., in the
docking zone 250) in the manner described. As shown, FIG. 4B is the
cross-sectional view of the stent graft system 400 that is cut away
in the docking zone 250 as shown in FIG. 4A.
[0087] The inflatable fill structure 430 is fixed, bonded,
attached, or otherwise coupled to the outer surface of the proximal
graft 212. In some examples, the inflatable fill structure 430 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the proximal graft 212 except for a portion of the outer
surface of the proximal graft 212 that is adjacent to the edge of
the proximal end of the proximal graft 212. In other examples, the
inflatable fill structure 430 is fixed, bonded, attached, or
otherwise coupled to the entire outer surface of the proximal graft
212. In some examples, in the inflated state, the inflatable fill
structure 430 surrounds the outer surface of the proximal graft 212
(as deployed in the aorta 10), including the portion of the
proximal graft 212 that is in the proximal neck region 17 and in
the sac of the aneurysm 14. As such, the stent graft system 400
differs from the stent graft system 200 in that the stent graft
system 400 does not include a separate seal component (e.g., the
seal component 240). Instead, the inflatable fill structure 430 can
provide the seal inside of the proximal neck region 17 (below or
distal to the renal arteries 15 and 16). Given that the separate
seal component is not provided and that a same component (e.g., the
inflatable fill structure 430) provides both sealing and sac
management functionalities, the stent graft system 400 is less
complex and thus easier and cheaper to manufacture.
[0088] In addition, the inflatable fill structure 432 is fixed,
bonded, attached, or otherwise coupled to the outer surface of the
limb stent graft 214a. The inflatable fill structure 434 is fixed,
bonded, attached, or otherwise coupled to the outer surface of the
limb stent graft 214b. Each of the inflatable fill structures 432
and 434 can be inflated using a dedicated fill line or a fill line
shared with another component of the stent graft system 400. When
inflated, the inflatable fill structures 432 and 434 expand
radially from the limb stent grafts 214a and 214b toward
surfaces/walls of the sac of the aneurysm 14. In the inflated
state, the inflatable fill structures 432 and 434 surround the limb
stent grafts 214a and 214b, respectively. As shown, the inflatable
fill structure 430 expands in and fills up an upper or proximal
portion of the sac of the aneurysm 14 while the inflatable fill
structures 432 and 434 expand in and fill up the bottom or distal
portion of the sac. The entire volume of the sac is accordingly
filled by the combination of the inflatable fill structures 430,
432, and 434.
[0089] In some examples, the inflatable fill structure 432 is
fixed, bonded, attached, or otherwise coupled to a portion (and not
an entirety) of the outer surface of the limb stent graft 214a. The
inflatable fill structure 432 (when inflated) surrounds a portion
(and not an entirety) of the outer surface of the limb stent graft
214a. For example, as shown, the inflatable fill structure 432 (in
the inflated state) surrounds a middle portion of the limb stent
graft 214a, where the middle portion is between the proximal end
(the portion that is inside of the docking zone 250 when deployed)
and the distal end (the portion that is inside of the iliac artery
12 when deployed) of the limb stent graft 214a. As such, the
inflatable fill structure 432 is not fixed, bonded, attached, or
otherwise coupled to, and does not surround, the portion of the
limb stent graft 214a that is inserted into the docking zone 250
and the portion of the limb stent graft 214a that is placed in the
iliac artery 12. With respect to the limb stent graft 214b, the
inflatable fill structure 434 is similar to the inflatable fill
structure 432.
[0090] In some examples, the inflatable fill structures 432 and 434
do not expand into the lumen of the proximal graft 212 that is in
the docking zone 250 to seal off the gutters 302. If the inflatable
fill structures 432 and 434 expand into the lumen of the proximal
graft 212, the limb stent grafts 214a and 214b (after docking) may
migrate down in the distal direction toward the aortic bifurcation
11 and out of the proximal graft 212 while the inflatable fill
structures 432 and 434 are being inflated. The gutters 302 (inside
of the lumen of the proximal graft 212) can be closed/sealed off by
the inflated inflatable fill structure 430 after the limb stent
grafts 214a and 214b are deployed inside of the proximal graft 212.
In other words, the inflatable fill structure 430 (in the inflated
state) fills up and seal the gutters 302 inside of the lumen of the
proximal graft 212. In this manner, the proximal graft fill lumen
stays connected while the proximal graft catheter is removed, in
order for the ipsi limb stent grafts 214a and 214b to be deployed.
In some arrangements, the portion of the proximal graft 212 that is
inside of the docking zone 250 is unsupported graft (e.g., PTFE,
without the stents) to conform around the limb stent grafts 214a
and 214b when the limb stent grafts 214a and 214b are docked inside
of the proximal graft 212.
[0091] FIG. 5 is a cross-sectional view of an example stent graft
system 500 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 4A-4B, and 5,
the stent graft system 500 includes the proximal graft 212, the
first limb stent graft 214a, the second limb stent graft 214b, the
inflatable fill structure 430, inflatable fill structures 532 and
534, and the anchor 245 (not shown for clarity). The proximal graft
212, the first limb stent graft 214a, the second limb stent graft
214b, the inflatable fill structure 430, and the anchor 245 are
components of the stent graft system 400 that are similar to and
confer similar improvements as the corresponding components of the
stent graft systems 200 and 400. In addition, as deployed in the
aorta 10, the first limb stent graft 214a and the second limb stent
graft 214b can be docked in the proximal graft 212 (e.g., in the
docking zone 250) in the manner described.
[0092] In some examples, the inflatable fill structure 532 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the limb stent graft 214a. The inflatable fill structure
534 is fixed, bonded, attached, or otherwise coupled to the entire
outer surface of the limb stent graft 214b. As such, the inflatable
fill structures 532 and 534 are fixed, bonded, attached, or
otherwise coupled to, and, in the inflated state, surround, in
addition to the middle portion, the portions of the limb stent
grafts 214a and 214b that are inserted into the docking zone 250
and the portions of the limb stent grafts 214a and 214b that are
placed in the iliac artery 12.
[0093] Each of the inflatable fill structures 532 and 534 can be
inflated using a dedicated fill line or a fill line shared with
another component of the stent graft system 500. When inflated, the
inflatable fill structures 532 and 534 expand radially from the
limb stent grafts 214a and 214b toward surfaces/walls of the sac of
the aneurysm 14. In the inflated state, the inflatable fill
structures 532 and 534 surround the entire outer surfaces of the
limb stent grafts 214a and 214b, respectively. As shown, the
inflatable fill structure 430 expands in and fills up an upper or
proximal portion of the sac of the aneurysm 14 while the inflatable
fill structures 532 and 534 expand in and fill up the bottom or
distal portion of the sac. The entire volume of the sac is
accordingly filled by the combination of the inflatable fill
structures 420, 532, and 534.
[0094] In some examples, the inflatable fill structures 532 and 534
expand into the lumen of the proximal graft 212 that is in the
docking zone 250 to seal of the gutters in the docking zone 250. In
such arrangements, the inflatable fill structure 430 can be filled
in the manner described, and the delivery system for the proximal
graft 212 and the inflatable fill structure 430 can be removed
prior to deploying the limb stent grafts 214a and 214b and
inflating the inflatable fill structures 532 and 534, thus deploy
the deployment operation.
[0095] FIG. 6A is a cross-sectional view of an example stent graft
system 600 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 6B is another cross-sectional view of
the example stent graft system 600 (FIG. 6A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. Referring
to FIGS. 1, 2, and 6A-6B, the stent graft system 600 includes the
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, an inflatable fill structure 630, and the
anchor 245. The proximal graft 212, the first limb stent graft
214a, the second limb stent graft 214b, and the anchor 245 are
components of the stent graft system 600 that are similar to and
confer similar improvements as the corresponding components of the
stent graft system 200. In addition, as deployed in the aorta 10,
the first limb stent graft 214a and the second limb stent graft
214b can be docked in the proximal graft 212 (e.g., in the docking
zone 250) in the manner described. As shown, FIG. 6B is the
cross-sectional view of the stent graft system 600 that is cut away
in the docking zone 250 as shown in FIG. 6A.
[0096] The inflatable fill structure 630 is fixed, bonded,
attached, or otherwise coupled to the outer surface of the proximal
graft 212. In some examples, the inflatable fill structure 630 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the proximal graft 212 except for a portion of the outer
surface of the proximal graft 212 that is adjacent to the edge of
the proximal end of the proximal graft 212. In other examples, the
inflatable fill structure 630 is fixed, bonded, attached, or
otherwise coupled to the entire outer surface of the proximal graft
212. In some examples, in the inflated state, the inflatable fill
structure 630 surrounds the outer surface of the proximal graft 212
(as deployed in the aorta 10), including the portion of the
proximal graft 212 that is in the proximal neck region 17 and in
the sac of the aneurysm 14. As such, the stent graft system 600
differs from the stent graft system 200 in that the stent graft
system 600 does not include a separate seal component (e.g., the
seal component 240). Instead, the inflatable fill structure 630 can
provide the seal inside of the proximal neck region 17 (below or
distal to the renal arteries 15 and 16).
[0097] In addition, the inflatable fill structure 630 is shaped to
seal off the gutters 302. The inflatable fill structure 630 is
shaped to extend into the sac of the aneurysm 14 and surround each
of the limb stent grafts 214a and 214b (including portions of the
limb stent grafts 214a and 214b that are outside of the docking
zone 250) when deployed. The inflatable fill structure 630 is
filled by the fill line 601 after the limb stent grafts 214a and
214b are docked inside of the single lumen of the proximal graft
212. As shown, as being filled to the inflated state, the
inflatable fill structure 630, which is fixed, bonded, attached, or
otherwise coupled to the external surface of the proximal graft
212, can extend in the distal direction toward the iliac arteries
12 and 13 and the aortic bifurcation 11 to surround the limb stent
grafts 214a and 214b while pushing against the surfaces/walls of
the sac of the aneurysm 14 radially. The limb stent grafts 214a and
214b do not have any inflatable fill structure fixed, bonded,
attached, or otherwise coupled. Accordingly, the inflatable fill
structure 630 can close off the gutters 302 (by virtue of
surrounding the limb stent grafts 214a and 214b) and fill the
aneurysm sac from the proximal neck region 17 to aortic bifurcation
11. In some examples (not shown), the inflatable fill structure 630
can even extend into the iliac arteries 12 and 13 while surrounding
the portions of the limb stent grafts 214a and 214b that are inside
of the iliac arteries 12 and 13.
[0098] As such, to seal the entire sac of the aneurysm 14,
including the gutters 302, the proximal neck region 17, and
sometimes even the iliac arteries 12 and 13, only one component
(the inflatable fill structure 630) is needed, and only one fill
line (the fill line 601) and one fill operation is needed to
perform both sealing and sac management functionalities, resulting
in a shorter procedural time. Given that the limb stent grafts 214a
and 214b do not have any inflatable fill structures, complexity and
costs of the stent graft system 600 are also lower.
[0099] FIG. 7 is a cross-sectional view of an example stent graft
system 700 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 7, the stent
graft system 700 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, the anchor 245, and a support component 702. The
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, the seal component 240, and the anchor 245
are components of the stent graft system 700 that are similar to
and confer similar improvements as the corresponding components of
the stent graft system 200. In addition, as deployed in the aorta
10, the first limb stent graft 214a and the second limb stent graft
214b can be docked in the proximal graft 212 (e.g., in the docking
zone 250) in the manner described.
[0100] An unsupported section 704 of the proximal graft 212 has the
graft material (e.g., the PTFE) without stent for structural
support. The unsupported section 704 is configured for proximal
extension. That is, the unsupported section 704 extends into the
proximal neck region 17 when the proximal graft 212 is deployed
within the aorta 10 in the manner described. The seal component 240
is attached, fixed, or otherwise coupled to the outer surface of
the unsupported section 704 of the proximal graft 212.
[0101] In some arrangements, the support component 702 is a support
ring or balloon made from a polymer (e.g., PTFE, polyurethane, and
so on). The support component 702 surrounds the portion of the
proximal graft 212 that is in the docking zone 250. In other words,
the support component 702 is attached, fixed, bonded (e.g.,
thermally bonded), sutured, or otherwise coupled to the proximal
graft 212, e.g., on the outer surface of the proximal graft 212. In
some examples, the portion of the proximal graft 212 that is in the
docking zone 250 is unsupported. In some examples, the entire
proximal graft 212 (including the docking zone 250 and the
unsupported section 704) are unsupported. The support component 702
can facilitate in cannulating the proximal graft 212 prior to or as
an inflatable fill structure (not shown) of the proximal graft 212
is being filled via a suitable fill line. Such an inflatable fill
structure can be fixed, bonded, attached, or otherwise coupled to
the outer surface of the proximal graft 212. In some examples, in
the inflated state, such an inflatable fill structure surrounds the
outer surface of the proximal graft 212 (as deployed in the aorta
10), including one or more of the portion of the proximal graft 212
that is in the proximal neck region 17, the portion of the proximal
graft 212 in the sac of the aneurysm 14, the gutters, and so on.
The support component 702 can be a support inflatable fill
structure that is inflated to provide structural integrity to the
unsupported proximal graft 212 (e.g., the portion that is in the
docking zone 250), before or while the inflatable fill structure is
inflated. The support component 702, in the inflated state,
provides structural integrity by preventing collapse of the
proximal graft 212. In some examples, the support component 702 can
be integrated with the delivery system that delivers the proximal
graft 212. That is, the support component 702 can be filled using
the catheter (a shared fill line) used to fill the proximal graft
212. Alternatively, the support component 702 can be filled using a
catheter separate from the catheter used for the delivery system
for the proximal graft 212. The support component 702 does not
increase the device profile.
[0102] FIG. 8 is a cross-sectional view of an example stent graft
system 800 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, 7, and 8, the stent
graft system 800 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, and the anchor 245. The proximal graft 212, the
first limb stent graft 214a, the second limb stent graft 214b, the
seal component 240, and the anchor 245 are components of the stent
graft system 800 that are similar to and confer similar
improvements as the corresponding components of the stent graft
system 200. In addition, as deployed in the aorta 10, the first
limb stent graft 214a and the second limb stent graft 214b can be
docked in the proximal graft 212 (e.g., in the docking zone 250) in
the manner described. As described, the unsupported section 704 of
the proximal graft 212 has the graft material (e.g., the PTFE)
without stent for structural support. In some examples, in addition
to the unsupported section 704, other portions of the proximal
graft 212 may be unsupported. In some examples, the entirety of the
proximal graft 212 is unsupported. The seal component 240 is
attached, fixed, or otherwise coupled to the outer surface of the
unsupported section 704 of the proximal graft 212.
[0103] In some arrangements, the proximal graft 212 includes a
wire-wound stent component 802 embedded therein. In some examples,
the wire-wound stent component 802 includes wire-wound stents
(having multiple wire-wound rings) and does not have any graft
material coupled thereto, such that the lumen of the proximal graft
212 is open at the wire-wound stent component 802 for easy
cannulation. In other examples, the wire-wound stent component 802
has graft material coupled thereto. The wire-wound stent component
802 is located at the distal end of the proximal graft 212 in some
examples. The wire-wound stent component 802 is located in the
docking zone 250 of the proximal graft 212 in some examples.
[0104] The wire-wound stent component 802 can facilitate
cannulating the proximal graft 212 prior to or as an inflatable
fill structure (not shown) of the proximal graft 212 is being
filled via a suitable fill line. Such an inflatable fill structure
can be fixed, bonded, attached, or otherwise coupled to the outer
surface of the proximal graft 212. In some examples, in the
inflated state, such an inflatable fill structure surrounds the
outer surface of the proximal graft 212 (as deployed in the aorta
10), including one or more of the portion of the proximal graft 212
that is in the proximal neck region 17, the portion of the proximal
graft 212 that is in the sac of the aneurysm 14, the gutters, and
so on. The wire-wound stent component 802 can provide structural
integrity to the proximal graft 212, before or while the inflatable
fill structure is inflated. The wire-wound stent component 802
provides structural integrity by preventing collapse of the
proximal graft 212 and avoiding kinking the lumen of the proximal
graft 212 in angulated anatomy. The wire-wound stent component 802
can provide improved mechanical locking between the proximal graft
212 and the limb stent grafts 214a and 214b in the docking zone 250
by providing a sufficient radial force to minimize the likelihood
of dislodgement between the proximal graft 212 and the limb stent
grafts 214a and 214b, thus improving joint separation resistance
and minimizing Type III Endoleaks.
[0105] FIG. 9 is a cross-sectional view of an example stent graft
system 900 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 7-9, the stent
graft system 900 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, and the anchor 245. The proximal graft 212, the
first limb stent graft 214a, the second limb stent graft 214b, the
seal component 240, and the anchor 245 are components of the stent
graft system 900 that are similar to and confer similar
improvements as the corresponding components of the stent graft
system 200. In addition, as deployed in the aorta 10, the first
limb stent graft 214a and the second limb stent graft 214b can be
docked in the proximal graft 212 (e.g., in the docking zone 250) in
the manner described. As described, the unsupported section 704 of
the proximal graft 212 has the graft material (e.g., the PTFE)
without stent for structural support. In some examples, in addition
to the unsupported section 704, other portions of the proximal
graft 212 may be unsupported. In some examples, the entirety of the
proximal graft 212 is unsupported. The seal component 240 is
attached, fixed, or otherwise coupled to the outer surface of the
unsupported section 704 of the proximal graft 212.
[0106] In some arrangements, the proximal graft 212 includes a
wire-wound stent ring 902 embedded therein. In some examples, the
wire-wound stent ring 902 includes a single ring of wire-wound
stent and does not have any graft material coupled thereto, such
that the lumen of the proximal graft 212 is open at the wire-wound
stent component 902 for easy cannulation. In other examples, the
wire-wound stent ring 902 has graft material coupled thereto. The
wire-wound stent ring 902 is located at the distal end of the
proximal graft 212 and abuts an edge of the proximal graft 212 in
some examples. The wire-wound stent ring 902 is located in the
docking zone 250 of the proximal graft 212 in some examples.
[0107] The wire-wound stent ring 902 can facilitate cannulating the
proximal graft 212 prior to or as an inflatable fill structure (not
shown) of the proximal graft 212 is being filled via a suitable
fill line. Such an inflatable fill structure can be fixed, bonded,
attached, or otherwise coupled to the outer surface of the proximal
graft 212. In some examples, in the inflated state, such an
inflatable fill structure surrounds the outer surface of the
proximal graft 212 (as deployed in the aorta 10), including one or
more of the portion of the proximal graft 212 that is in the
proximal neck region 17, the portion of the proximal graft 212 that
is in the sac of the aneurysm 14, the gutters, and so on. The
wire-wound stent ring 902 can provide structural integrity to the
proximal graft 212, before or while the inflatable fill structure
is inflated. The wire-wound stent ring 902 provides structural
integrity by preventing collapse of the proximal graft 212 and
avoiding kinking the lumen of the proximal graft 212 in angulated
anatomy. The wire-wound stent ring 902 can provide improved
mechanical locking between the proximal graft 212 and the limb
stent grafts 214a and 214b in the docking zone 250 by providing a
sufficient radial force to minimize the likelihood of dislodgement
between the proximal graft 212 and the limb stent grafts 214a and
214b, thus improving joint separation resistance and minimizing
Type III Endoleaks.
[0108] FIG. 10 is a cross-sectional view of an example stent graft
system 1000 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 10, the stent
graft system 1000 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, a seal
component 1240, the anchor 245, an inflatable fill structure 1002,
and an inflatable fill structure 1004. The proximal graft 212, the
first limb stent graft 214a, the second limb stent graft 214b, and
the anchor 245 are components of the stent graft system 1000 that
are similar to and confer similar improvements as the corresponding
components of the stent graft system 200. In some arrangements, the
seal component 1240 is similar to the seal component 240, except
that the seal component 1240 is wider such that a portion of the
seal component 1240 extends outside of the proximal neck region 17
and inside of the sac of the aneurysm 14. As deployed in the aorta
10, the first limb stent graft 214a and the second limb stent graft
214b can be docked in the proximal graft 212 (e.g., in the docking
zone 250) in the manner described. In some examples, the portion of
the proximal graft 212 that is in the docking zone 250 includes the
wire-wound stent ring 902. In some examples, the wire-wound stent
ring 902 includes a single ring of wire-wound stent and does not
have any graft material coupled thereto, such that the lumen of the
proximal graft 212 is open at the wire-wound stent component 902
for easy cannulation.
[0109] In some arrangements, each of the limb stent grafts 214a and
214b includes a respective one of wire-wound stent components 1012
and 1014 embedded therein. In some examples, each of the wire-wound
stent components 1012 and 1014 includes wire-wound stents (having
multiple wire-wound rings) and does not have any graft material
coupled thereto, such that the lumen of each of the limb stent
grafts 214a and 214b is open at the respective one of the
wire-wound stent components 1012 and 1014 for easy cannulation. In
other examples, the wire-wound stent components 1012 and 1014 have
graft material coupled thereto. Each of the wire-wound stent
components 1012 and 1014 is located at the distal end of the
respective one of the limb stent grafts 214a and 214b in some
examples and is placed in the iliac arteries 12 and 13 when
deployed.
[0110] The inflatable fill structure 1002 is fixed, bonded,
attached, or otherwise coupled to at least a portion of the outer
surface of the limb stent graft 214a. The inflatable fill structure
1004 is fixed, bonded, attached, or otherwise coupled to at least a
portion of the outer surface of the limb stent graft 214b. Each of
the inflatable fill structures 1002 and 1004 can be inflated using
a dedicated fill line or a fill line shared with another component
of the stent graft system 1000. When inflated, the inflatable fill
structures 1002 and 1004 expand radially from the limb stent grafts
214a and 214b toward surfaces/walls of the sac of the aneurysm 14.
In the inflated state, the inflatable fill structures 1002 and 1004
surround the limb stent grafts 214a and 214b, respectively.
[0111] In some examples, the inflatable fill structure 1002 is
fixed, bonded, attached, or otherwise coupled to a portion (and not
an entirety) of the outer surface of the limb stent graft 214a. The
inflatable fill structure 1002 (when inflated) surrounds a portion
(and not an entirety) of the outer surface of the limb stent graft
214a. In some arrangements, the inflatable fill structure 1002 is
not fixed, bonded, attached, or otherwise coupled to, and does not
surround, the portion of the limb stent graft 214a that is placed
in the iliac artery 12 when deployed or the portion of the limb
stent graft 214a corresponding to the wire-wound stent components
1012 and 1014. In other arrangements, the inflatable fill structure
1002 is fixed, bonded, attached, or otherwise coupled to, and
surrounds, the portion of the limb stent graft 214a that is placed
in the iliac artery 12 when deployed or the portion of the limb
stent graft 214a corresponding to the wire-wound stent components
1012 and 1014. With respect to the limb stent graft 214b, the
inflatable fill structure 1004 is similar to the inflatable fill
structure 1002. In some arrangements, the inflatable fill
structures 1002 and 1004 are not fixed, bonded, attached, or
otherwise coupled to, and do not surround, the portions of the
respective ones of the limb stent grafts 214a and 214b that are
inserted into the docking zone 250. In some examples, the
inflatable fill structures 1002 and 1004 surround the stent grafts
214a and 214b that are outside of the docking zone 250 contacting
the edge of the distal end of the proximal graft 212 to seal off
the gutters. In some examples, the inflatable fill structures 1002
and 1004 expand into the lumen of the proximal graft 212 that is in
the docking zone 250 to seal off the gutters.
[0112] Furthermore, the inflatable fill structures 1002 and 1004
are shaped to extend into the sac of the aneurysm 14 and surround
the portion of the proximal graft 212 that is in the sac when
deployed. As shown, while being filled to the inflated state, the
inflatable fill structures 1002 and 1004 can extend in the proximal
direction toward the proximal neck region 17 to surround the
proximal graft 212 while pushing against the surfaces/walls of the
sac of the aneurysm 14 radially. The proximal graft 212 does not
have any inflatable fill structure fixed, bonded, attached, or
otherwise coupled. Given that no inflatable fill structure is
provided for the stent graft, the stent graft system 1000 is
cheaper to manufacture. As shown, the entire volume of the sac is
accordingly filled by the inflatable fill structures 1002 and
1004.
[0113] In some examples, instead of the two inflatable fill
structures 1002 and 1004, a single inflatable fill structure fixed,
bonded, attached, or otherwise coupled to either one or both of the
limb stent grafts 214a and 214b can be used to surround the limb
stent grafts 214a and 214b as well as to extend into the sac of the
aneurysm 14 and surround the portion of the proximal graft 212 that
is in the sac when deployed.
[0114] FIG. 11A is a cross-sectional view of an example stent graft
system 1100 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 11B is another cross-sectional view of
the example stent graft system 1100 (FIG. 11A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. Referring
to FIGS. 1, 2, and 10-11B, the stent graft system 1100 includes the
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, the seal component 240, the anchor 245, and
the inflatable fill structures 1002 and 1004. The proximal graft
212, the first limb stent graft 214a, the second limb stent graft
214b, the seal component 240, and the anchor 245 are components of
the stent graft system 1100 that are similar to and confer similar
improvements as the corresponding components of the stent graft
system 200. In addition, the inflatable fill structures 1002 and
1004 are components of the stent graft system 1100 that are similar
to and confer similar improvements as the corresponding components
of the stent graft system 1000. The stent graft system 1100 is
different from the stent graft system 1000 in that the proximal
graft 212 of the stent graft system 1100 does not include the
wire-wound stent component 902, and the limb stent grafts 214a and
214b of the stent graft system 1100 do not include the wire-wound
stent components 1012 and 1014. As described, the unsupported
section 704 of the proximal graft 212 has the graft material (e.g.,
the PTFE) without stent for structural support.
[0115] As described, the inflatable fill structures 1002 and 1004
are fixed, bonded, attached, or otherwise coupled to and surround
at least portions of the outer surface of the limb stent grafts
214a and 214b. In the examples in which the inflatable fill
structures 1002 and 1004 are not fixed, bonded, attached, or
otherwise coupled to, and do not surround, the portions of the
respective ones of the limb stent grafts 214a and 214b that are
inserted into the docking zone 250, the inflatable fill structures
1002 and 1004 are shaped to extend into the sac of the aneurysm 14
and surround the portion of the proximal graft 212 that is in the
sac when deployed. In other arrangements, the inflatable fill
structures 1002 and 1004 are fixed, bonded, attached, or otherwise
coupled to, and surround, the portions of the respective ones of
the limb stent grafts 214a and 214b that are inserted into the
docking zone 250. In such arrangements, when being inflated by a
dedicated or shared fill line, each of the inflatable fill
structures 1002 and 1004 can expand within the lumen of the
proximal graft 212 to seal off the gutters 302.
[0116] FIG. 12 is a cross-sectional view of an example stent graft
system 1200 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 12, the stent
graft system 1200 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, the anchor 245, and inflatable fill structures 1202,
1204, and 1230. The proximal graft 212, the first limb stent graft
214a, the second limb stent graft 214b, the seal component 240, and
the anchor 245 are components of the stent graft system 1200 that
are similar to and confer similar improvements as the corresponding
components of the stent graft system 200.
[0117] In some examples, a shape and compliance (elasticity) of the
inflatable fill structure 1230 allow the inflatable fill structure
1230 to form a funnel when inflated within the sac of the aneurysm
14. For example, the inflatable fill structure 1230 is similar to
the inflatable fill structure 230, except that the inflatable fill
structure 1230, when being filled, expands radially toward the
surfaces/walls of the sac of the aneurysm 14 and also in the distal
direction toward the iliac arteries 12 and 13, such that the
portion of the inflatable fill structure 1230 abutting and adjacent
to the surfaces/walls of the sac of the aneurysm 14 extend (e.g.,
along the surfaces/walls of the sac of the aneurysm 14) farther in
the distal direction as compared to the potions of the of the
inflatable fill structure 1230 abutting and adjacent to the
proximal graft 212, thus creating the funnel shape. The inflatable
fill structure 1230 is made from material that is sufficiently soft
and elastic to allow the inflatable fill structure 1230 to form the
funnel shape.
[0118] The funnel shape is used to facilitate cannulation. In one
example, the proximal graft 212 can be deployed within the aorta 10
in the manner described. The inflatable fill structure 1230 can be
inflated to form the funnel shape. The limb stent grafts 214a and
214b can be inserted into the lumen of the proximal graft 212 as
guided by the funnel shape of the inflatable fill structure 1230.
That is, the sloped surface of the inflatable fill structure 1230
can guide the proximal ends of the limb stent grafts 214a and 214b
into the lumen of the proximal graft 212 as the limb stent grafts
214a and 214b move in the proximal direction toward the proximal
neck region 17. In another example, the limb stent grafts 214a and
214b can be deployed within the aorta 10 in the manner described.
While the proximal graft 212 is being inserted into the aorta 10,
the inflatable fill structure 1230 can be inflated to form the
funnel shape. The sloped surface of the of the inflatable fill
structure 1230 can guide the proximal graft 212 so that the limb
stent grafts 214a and 214b can be inserted into the lumen of the
proximal graft 212 as the proximal graft 212 move in the distal
direction. In some examples, the stent graft delivery system uses
an integrated contra wire instead of cannulating retrograde into
the large bore of the proximal graft 212.
[0119] In some examples, the seal component 240 can be made from a
material (e.g., polyesters, PTFE, polyurethane, and so on) that is
less compliant than the material (e.g., PTFE, a low-durometer
polyurethane, and so on) from which the inflatable fill structure
1230 is made. The less compliant seal component 240 (approximately
1 cm in width) can provide a tighter seal in the proximal neck
region 17.
[0120] The inflatable fill structure 1202 is fixed, bonded,
attached, or otherwise coupled to the entire outer surface of the
limb stent graft 214a (including the portions of the limb stent
graft 214a that is placed in the iliac artery 12 and in the docking
zone 250) when deployed. The inflatable fill structure 1204 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the limb stent graft 214b (including the portions of the
limb stent graft 214b that is placed in the iliac artery 13 and in
the docking zone 250) when deployed. Each of the inflatable fill
structures 1202 and 1204 can be inflated using a dedicated fill
line or a fill line shared with another component of the stent
graft system 1200. When inflated, the inflatable fill structures
1202 and 1204 expand radially from the limb stent grafts 214a and
214b toward surfaces/walls of the sac of the aneurysm 14. As such,
the entire volume of the sac is accordingly filled by the
combination of the inflatable fill structures 1202, 1204, and 1230.
In the inflated state, the inflatable fill structures 1202 and 1204
surround the limb stent grafts 214a and 214b, respectively. The
inflatable fill structures 1202 and 1204 can also expand within the
lumen of the proximal graft 212 to seal off any gutters therein.
Furthermore, the inflatable fill structures 1202 and 1204 can
expand within the iliac arties 12 and 13 to form a seal in the
iliac arties 12 and 13 when the limb stent grafts 214a and 214b are
deployed.
[0121] FIG. 13A is a cross-sectional view of an example stent graft
system 1300 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 13B is another cross-sectional view of
the example stent graft system 1300 (FIG. 13A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. Referring
to FIGS. 1, 2, 13A, and 13B, the stent graft system 1300 includes
the proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, the seal component 240, the anchor 245, and
at least one support components (e.g., support components 1302 and
1304). The proximal graft 212, the first limb stent graft 214a, the
second limb stent graft 214b, the seal component 240, and the
anchor 245 are components of the stent graft system 1300 that are
similar to and confer similar improvements as the corresponding
components of the stent graft system 200. In addition, as deployed
in the aorta 10, the first limb stent graft 214a and the second
limb stent graft 214b can be docked in the proximal graft 212
(e.g., in the docking zone 250) in the manner described.
[0122] To seal any gutters that may form in the lumen of the
proximal graft 212 when the limb stent grafts 214a and 214b are
inserted in the lumen of the proximal graft 212, the at least one
support components (e.g., the support components 1302 and 1304) are
embedded in the proximal graft 212. In some arrangements, the
support components 1302 and 1304 are support inflatable fill
structures such as but not limited to, support rings or balloons
made from a polymer (e.g., PTFE, polyurethane, and so on). The
support components 1302 and 1304 are embedded in the portion of the
proximal graft 212 that is in the docking zone 250. The support
components 1302 and 1304 are attached, fixed, bonded (e.g.,
thermally bonded), sutured, or otherwise coupled to the proximal
graft 212 such that an interior portion (including an inner surface
portion) of each of the support components 1302 and 1304 is inside
of the lumen of the proximal graft 212 while the remaining exterior
portion (including an outer surface portion) of the support
components 1302 and 1304 is outside of the proximal graft 212. In
some examples, the portion of the proximal graft 212 that is in the
docking zone 250 is unsupported.
[0123] After the proximal graft 212 is deployed in the aorta 10 in
the manner described, each of the support components 1302 and 1304
can be inflated using a dedicated fill line or a shared fill line
shared with another component of the stent graft system 1300. In
some examples, each of the support components 1302 and 1304 can be
pre-shaped using a bi-lobe balloon on the catheter used to deploy
the proximal graft 212, where the support components 1302 and 1304
are inflated around the bi-lobe balloon on the catheter.
Accordingly, in the inflated state, each of the support components
1302 and 1304 forms an opening 1306 (commensurate with the shape of
the bi-lobe balloon on the catheter) through which the limb stent
grafts 214a and 214b can be inserted. The opening 1306 appears to
be a bi-lobe opening. Given that the support components 1302 and
1304 are elastic, and the opening 1306 is slightly smaller than the
sum of the cross-section area of the proximal ends of the limb
stent grafts 214a and 214b, the support components 1302 and 1304
form tight seals around the limb stent grafts 214a and 214b when
inserted. While two support components 1302 and 1304 are shown, one
or three or more support components such as but not limited to, the
support components 1302 and 1304 can be implemented.
[0124] The implementation of the support components 1302 and 1304
allows the stent graft system 1300 to seal off the gutters without
needing inflatable fill structures such as endobags. If there are
no type II Endoleaks present, physicians may select the stent graft
system 1300 given that not filling the entire sac of the aneurysm
14 with polymer (e.g., the endobags) is preferred.
[0125] FIG. 14 is a cross-sectional view of an example stent graft
system 1400 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 14, the stent
graft system 1400 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, seal components
1402 and 1440, the anchor 245, and at least one internal support
components (e.g., the internal support component 1404). The
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, and the anchor 245 are components of the
stent graft system 1400 that are similar to and confer similar
improvements as the corresponding components of the stent graft
system 200. In some examples, the anchor 245 of the stent graft
system 1400 can be fixed or attached to the proximal end of the
proximal graft 212 or to the seal component 1440. The seal
component 1440 is similar to the seal component 240, except that
the seal component 1440 is narrower as compared to the seal
component 240 in some arrangements. In addition, as deployed in the
aorta 10, the first limb stent graft 214a and the second limb stent
graft 214b can be docked in the proximal graft 212 (e.g., in the
docking zone 250) in the manner described. As shown, a portion of
the docking zone 250 is in the proximal neck region 17 while the
remaining portion of the docking zone 250 is in the sac of the
aneurysm 14. The proximal graft 212 is shown to have wire-wound
stents (having multiple wire-wound rings) in addition to the graft
material (e.g., the proximal graft 212 in FIG. 14 is a stent
graft).
[0126] In some examples, the seal component 1402 is coupled to the
distal end of the proximal graft 212 to seal the gutters formed
when the limb stent grafts 214a and 214b are inserted into the
lumen of the proximal graft 212 in the docking zone 250. The seal
component 1402 can be an inflatable fill structure made from a
polymer (e.g., PTFE, polyurethane, and so on) that can be inflated
using a dedicated fill line or a shared fill line shared with
another component of the stent graft system 1400. In the inflated
state, the seal component 1402 may have a single bi-lobe opening or
two openings to receive the proximal ends of the limb stent grafts
214a and 214b. Given the elasticity of the material of the seal
component 1402, the seal component 1402 forms a seal around the
limb stent grafts 214a and 214b at the lumen opening of the
proximal graft 212.
[0127] To provide additional sealing features to seal the gutters
that may form in the lumen of the proximal graft 212 when the limb
stent grafts 214a and 214b are inserted in the lumen of the
proximal graft 212, the internal support component 1404 is embedded
in the proximal graft 212. In some arrangements, the internal
support component 1404 is a support inflatable fill structure such
as but not limited to, an endobag made from a polymer (e.g., PTFE,
polyurethane, and so on). The internal support component 1404 is
embedded in the portion of the proximal graft 212 that is in the
docking zone 250. The internal support component 1404 is attached,
fixed, bonded (e.g., thermally bonded), sutured, or otherwise
coupled to the internal surface of the proximal graft 212. The
internal surface of the proximal graft 212 faces the lumen of the
proximal graft 212. The internal support component 1404 expands
within the lumen of the proximal graft 212 when filled.
[0128] After the proximal graft 212 is deployed in the aorta 10 in
the manner described, the limb stent grafts 214a and 214b are
inserted into the lumen of the proximal graft 212. The internal
support component 1404 can be inflated using a dedicated fill line
or a shared fill line shared with another component of the stent
graft system 1400 after the limb stent grafts 214a and 214b are
inserted. In the inflated state, the internal support component
1404 forms a seal around the proximal ends of the limb stent grafts
214a and 214b, including a space between the limb stent grafts 214a
and 214b and a space between the inner surface of the proximal
graft 212 and each of the limb stent grafts 214a and 214b, as
shown. Given that the internal support component 1404 is elastic
(e.g., more compliant than a polymer support ring such as the
support components 1302 and 1304), and that the internal support
component 1404 is inflated inward within the lumen of the proximal
graft 212, the internal support component 1404 can form a tight
seal around the limb stent grafts 214a and 214b when inserted.
While one internal support component 1404 is shown, two or more
internal support components such as but not limited to, the
internal support component 1404 can be implemented.
[0129] FIG. 15A is a cross-sectional view of an example stent graft
system 1500 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. FIG. 15B is another cross-sectional view of
the example stent graft system 1500 (FIG. 15A) deployed across the
aneurysm 14 (FIG. 1) according to various arrangements. FIG. 15C is
yet another cross-sectional view of the example stent graft system
1500 (FIG. 15A) deployed across the aneurysm 14 (FIG. 1) according
to various arrangements. Referring to FIGS. 1, 2, 4A-4B, and
15A-15C the stent graft system 1500 includes the proximal graft
212, the first limb stent graft 214a, the second limb stent graft
214b, the inflatable fill structures 430, 432, and 434, the anchor
245, and an internal inflatable fill structure 1502. The proximal
graft 212, the first limb stent graft 214a, the second limb stent
graft 214b, and the anchor 245 are components of the stent graft
system 1500 that are similar to and confer similar improvements as
the corresponding components of the stent graft system 200. As
deployed in the aorta 10, the first limb stent graft 214a and the
second limb stent graft 214b can be docked in the proximal graft
212 (e.g., in the docking zone 250) in the manner described.
[0130] In addition, the inflatable fill structures 430, 432, and
434 are components of the stent graft system 1500 that are similar
to and confer similar improvements as the corresponding components
of the stent graft system 400, except that the inflatable fill
structure 430 (in the inflated state) does not fills up or seal the
gutters inside of the lumen of the proximal graft 212. Instead, the
internal inflatable fill structure 1502 can be inflated to seal the
gutters.
[0131] For example, to seal the gutters that may form in the lumen
of the proximal graft 212 when the limb stent grafts 214a and 214b
are inserted in the lumen of the proximal graft 212, the internal
inflatable fill structure 1502 is embedded in the proximal graft
212. In some arrangements, the internal inflatable fill structure
1502 is a support inflatable fill structure such as but not limited
to, an endobag made from a polymer (e.g., PTFE, polyurethane, and
so on). The internal inflatable fill structure 1502 is attached,
fixed, bonded (e.g., thermally bonded), sutured, or otherwise
coupled to the entire internal surface of the proximal graft 212.
The internal surface of the proximal graft 212 faces the lumen of
the proximal graft 212. The internal inflatable fill structure 1502
expands within the lumen of the proximal graft 212 when filled.
[0132] In some examples, in the inflated state, the internal
inflatable fill structure 1502 includes a proximal portion (the
cross section of which is shown in FIG. 15B) corresponding to the
proximal end of the proximal graft 212 and a distal portion (the
cross section of which is shown in FIG. 15C) corresponding to the
distal end of the proximal graft 212. The distal portion of the
internal inflatable fill structure 1502 corresponds to the docking
zone 250. When filled, the proximal portion of the internal
inflatable fill structure 1502 forms a large lumen while the distal
portion of the internal inflatable fill structure 1502 forms a
bi-lobe lumen. The internal inflatable fill structure 1502 can be
pre-shaped by a catheter used to deploy the proximal graft 212. For
example, after the proximal graft 212 is deployed in the aorta 10
in the manner described, the proximal portion of the internal
inflatable fill structure 1502 is inflated around a balloon of the
catheter having a circular or oval cross section while the distal
portion of the internal inflatable fill structure 1502 is inflated
around a bi-lobe balloon of the catheter. As such, the internal
inflatable fill structure 1502 form a bifurcated lumen within the
lumen of the proximal graft 212. The internal inflatable fill
structure 1502 can be inflated using a dedicated fill line or a
shared fill line shared with another component of the stent graft
system 1500 before the limb stent grafts 214a and 214b are
inserted.
[0133] In the inflated state, the distal portion of the internal
inflatable fill structure 1502 forms a seal around the proximal
ends of the limb stent grafts 214a and 214b, including a space
between the limb stent grafts 214a and 214b and a space between the
inner surface of the proximal graft 212 and each of the limb stent
grafts 214a and 214b, as shown. Given that the internal inflatable
fill structure 1502 is elastic, and that the internal support
component 1404 is inflated inward within the lumen of the proximal
graft 212, the internal inflatable fill structure 1502 can form a
tight seal around the limb stent grafts 214a and 214b when
inserted.
[0134] FIG. 16 is a cross-sectional view of an example stent graft
system 1600 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 16, the stent
graft system 1600 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the seal
component 240, an inflatable fill structure 1630, and an anchor
1645. The proximal graft 212, the first limb stent graft 214a, the
second limb stent graft 214b, and the seal component 240 are
components of the stent graft system 1600 that are similar to and
confer similar improvements as the corresponding components of the
stent graft system 200. The anchor 1645 is similar to the anchor
245, except that the anchor 1645 includes wire-wound stents having
multiple wire-wound rings. The anchor 1645 includes hooks or barbs
on the wire-wound stents that anchor, fix, or attach to the
walls/surfaces of the aorta 10 that are proximal relative to the
renal ostia and the proximal neck region 17. As deployed in the
aorta 10, the first limb stent graft 214a and the second limb stent
graft 214b can be docked in the proximal graft 212 (e.g., in the
docking zone 250) in the manner described. The limb stent grafts
214a and 214b are shown to include wire-wound stents having
multiple wire-wound rings in some examples.
[0135] The inflatable fill structure 1630 is fixed, bonded,
attached, or otherwise coupled to the outer surface of the proximal
graft 212. In some examples, the inflatable fill structure 1630 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the proximal graft 212 except for a portion of the outer
surface of the proximal graft 212 that is adjacent to the edge of
the proximal end of the proximal graft 212. In other examples, the
inflatable fill structure 1630 is fixed, bonded, attached, or
otherwise coupled to the entire outer surface of the proximal graft
212.
[0136] The inflatable fill structure 1630 is a bifurcated
inflatable fill structure or endobag, such that in the inflated
state, the inflatable fill structure 1630 surrounds the outer
surface of the proximal graft 212 (as deployed in the aorta 10)
while providing two lumens for receiving limb stent grafts 214a and
214b. The inflatable fill structure 1630 can be pre-shaped by a
catheter used to deploy the proximal graft 212. For example, after
the proximal graft 212 is deployed in the aorta 10 in the manner
described, the inflatable fill structure 1630 is inflated around a
bifurcated balloon of the catheter to shape the lumens for
receiving limb stent grafts 214a and 214b, while the inflatable
fill structure 1630 expands radially toward the surfaces/walls of
the sac of the aneurysm 14 to fill up the entire sac except for the
lumen of the proximal graft 212 and the bifurcated balloon. The
inflatable fill structure 1630 can be inflated using a dedicated
fill line or a shared fill line shared with another component of
the stent graft system 1600 before the limb stent grafts 214a and
214b are inserted. After, the limb stent grafts 214a and 214b can
be inserted into the lumens of the inflatable fill structure 1630
and the lumen of the proximal graft 212. The lumens of the
inflatable fill structure 1630 lead to and are in communication
with the lumen of the proximal graft 212. The inflatable fill
structure 1630 can surround the limb stent grafts 214a and 214b and
provide a tight seal, including in the area around the docking zone
250 to seal the gutters. Given that the inflatable fill structure
1630 can seal the gutters while filling up the entire sac, thus
only one polymer fill step is needed in the stent graft system
1600. The limb stent grafts 214a and 214b also do not need
additional inflatable fill structures coupled thereto, thus
reducing complexity and cost.
[0137] FIG. 17 is a cross-sectional view of an example stent graft
system 1700 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 17, the stent
graft system 1700 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, a seal
component 1740, the anchor 245, and inflatable fill structures
1702, 1704, and 1730. The proximal graft 212, the first limb stent
graft 214a, the second limb stent graft 214b, and the anchor are
components of the stent graft system 1700 that are similar to and
confer similar improvements as the corresponding components of the
stent graft system 200. As shown, each of the stent grafts 214a and
214b includes stents having multiple rings. In some examples, the
stent grafts 214a and 214b include Nellix stents. As deployed in
the aorta 10, the first limb stent graft 214a and the second limb
stent graft 214b can be docked in the proximal graft 212 (e.g., in
the docking zone 250) in the manner described.
[0138] As shown, the proximal graft 212 includes a laminated stent
component such as but not limited to, Teflon-laminated
nickel-titanium (NiTi)-stents. The laminated stent component
prevents the lumen of the proximal graft 212 from kinking and
collapsing in angulated anatomies and during polymer filling of the
inflatable fill structure 1730, which may be soft. Providing the
laminated stent component eliminates the need for a support balloon
on the delivery system that delivers the proximal graft 212 into
the aorta 10, thus resulting in reduced cost and reduced
profile.
[0139] The seal component 1740 is similar to the seal component
240, except that the seal component 1740 is narrower as compared to
the seal component 240 in some arrangements. In some examples, the
seal component 1740 can be made from a material (e.g., polyesters,
PTFE, polyurethane, and so on) that is less compliant than the
material (e.g., PTFE, a low-durometer polyurethane, and so on) from
which the inflatable fill structure 1730 is made.
[0140] The less compliant and more rigid seal component 1740
(approximately 1 cm in width) can provide a tighter seal in the
proximal neck region 17 and a more defined edge than a soft
endobag. The more defined edge at the proximal end of the proximal
graft 212 can improve proximal placement accuracy.
[0141] The inflatable fill structure 1730 is fixed, bonded,
attached, or otherwise coupled to at least a portion of the outer
surface of the proximal graft 212. In some examples, the inflatable
fill structure 1730 is fixed, bonded, attached, or otherwise
coupled to the entire outer surface of the proximal graft 212
except for a portion of the outer surface of the proximal graft 212
that is coupled to the seal component 1740. In some examples, in
the inflated state, the inflatable fill structure 1730 surrounds
the outer surface of the proximal graft 212 (as deployed in the
aorta 10), including a portion of the proximal graft 212 that is in
the proximal neck region 17 and in the sac of the aneurysm 14.
[0142] The inflatable fill structure 1702 is fixed, bonded,
attached, or otherwise coupled to the entire outer surface of the
limb stent graft 214a (including the portions of the limb stent
graft 214a that is placed in the iliac artery 12 and in the docking
zone 250) when deployed. The inflatable fill structure 1704 is
fixed, bonded, attached, or otherwise coupled to the entire outer
surface of the limb stent graft 214b (including the portions of the
limb stent graft 214b that is placed in the iliac artery 13 and in
the docking zone 250) when deployed. Each of the inflatable fill
structures 1702 and 1704 can be inflated using a dedicated fill
line or a fill line shared with another component of the stent
graft system 1700. When inflated, the inflatable fill structures
1702 and 1704 expand radially from the limb stent grafts 214a and
214b toward surfaces/walls of the sac of the aneurysm 14. As such,
the entire volume of the sac is accordingly filled by the
combination of the inflatable fill structures 1702, 1704, and 1730.
In The inflatable fill structures 1702 and 1704 can also expand
within the lumen of the proximal graft 212 to seal off any gutters
therein. Furthermore, the inflatable fill structures 1702 and 1704
can expand within the iliac arties 12 and 13 to form a seal in the
iliac arties 12 and 13 when the limb stent grafts 214a and 214b are
deployed.
[0143] FIG. 18 is a cross-sectional view of an example stent graft
system 1800 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1, 2, and 18, the stent
graft system 1800 includes a laminated stent component 1812, the
first limb stent graft 214a, the second limb stent graft 214b, a
seal component 1840, an anchor 1845, locking features 1852 and
1854, and inflatable fill structure 1830. The first limb stent
graft 214a and the second limb stent graft 214b are components of
the stent graft system 1800 that are similar to and confer similar
improvements as the corresponding components of the stent graft
system 200. As shown, each of the stent grafts 214a and 214b
includes stents having multiple rings. In some examples, the stent
grafts 214a and 214b include Nellix stents. As deployed in the
aorta 10, the first limb stent graft 214a and the second limb stent
graft 214b can be docked in the laminated stent component 1812
(e.g., in the docking zone 250) in the manner described.
[0144] As shown, the laminated stent component 1812 includes a
component such as but not limited to, Teflon-laminated
Nickel-Titanium (NiTi)-stents. The laminated stent can be
wire-wound or laser-cut. The laminated stent component prevents the
lumen of the laminated stent component 1812 from kinking and
collapsing in angulated anatomies and during polymer filling of the
inflatable fill structure 1830, which may be soft. Providing the
laminated stent component eliminates the need for a support balloon
on the delivery system that delivers the laminated stent component
1812 into the aorta 10, thus resulting in reduced cost and reduced
profile. After the inflatable fill structure 1830 is filled, the
limbs stent grafts 214a and 214b (which may be Nellix) are inserted
into the laminated stent component 1812 in the docking zone
250.
[0145] The inflatable fill structure 1830 is fixed, bonded,
attached, or otherwise coupled to at least a portion of the outer
surface of the laminated stent component 1812. In some examples,
the inflatable fill structure 1830 is fixed, bonded, attached, or
otherwise coupled to the entire outer surface of the proximal graft
212 except for a portion of the outer surface of the laminated
stent component 1812 that is coupled to the seal component 1840. In
some examples, in the inflated state, the inflatable fill structure
1830 surrounds the outer surface of the laminated stent component
1812 (as deployed in the aorta 10), including a portion of the
laminated stent component 1812 that is in the proximal neck region
17 and in the sac of the aneurysm 14. In some arrangements, in the
inflated state and when deployed, the inflatable fill structure
1830 surrounds or encapsulate the outer surface of a portion of the
seal component 1840 that is inside of the sac of the aneurysm 14.
In some examples, the inflatable fill structure 1830 extends in the
distal direction toward the aortic bifurcation 11 and the iliac
arteries 12 and 13 to fill up the entirety of the sac of the
aneurysm 14.
[0146] In some example, the anchor 1845 can be hooks or barbs on
the stents of the laminated stent component 1812. As shown, the
hooks or barbs of the anchor 1845 are located on the stent ring
that is closest to the renal arteries 15 and 16. The hooks or barbs
of the anchor 1845 can be located on another stent ring of the
laminated stent component 1812 as well as on more than one stent
ring of the laminated stent component 1812.
[0147] The seal component 1840 can be an inflatable seal ring. In
some implementations, the seal component 1840 is coupled to the
laminated stent component 1812. For example, the seal component
1840 is attached, fixed, or otherwise coupled to the outer surface
of the proximal end of the laminated stent component 1812. In the
inflated state, the seal component 240 surrounds the portion of the
laminated stent component 1812 that is in the proximal neck region
17 and in the sac of the aneurysm 14 when the laminated stent
component 1812 is deployed. In some example, when the seal
component 1840 is in the inflated state, the seal component 1840
does not reach and does not extend past the edge of the proximal
end of the laminated stent component 1812 such that a portion
(e.g., the portion with the anchor 1845) of the laminated stent
component 1812 adjacent to the edge of the proximal end of the
laminated stent component 1812 is not surrounded by the seal
component 1840. Generally, a device having a seal component of a
certain width can be deployed in a range of neck lengths of the
aortic neck region 17, meaning that a seal component having an
inflated width longer than the neck length cannot be deployed in
the aortic neck region 17 of a subject having that neck length. On
the other hand, the stent graft systems described herein (e.g., the
stent graft system 1800) can be deployed in the aorta 10 of
subjects having a neck length that is shorter than the neck lengths
deployable by other devices. This is because if the neck length of
the aortic neck region 17 is short, the seal component 1840 is
configured to extend into the sac of the aneurysm 14 (while the
anchor 1845 is fixed to the wall of the aortic neck region 17) when
the seal component 1840 does not otherwise have any space to expand
in the aortic neck region 17. The portion of the seal component
1840 that is in the sac of the aneurysm 14 can be used in
conjunction with the inflatable fill structure 1830 (e.g., the
inflatable fill structure 1830 encapsulate the portion the seal
component 1840 that is in the sac) for sac management.
[0148] Each of the locking features 1852 and 1854 includes a
polymer seal sack on the proximal ends of a respective one of the
limbs stent grafts 214a and 214b. In some arrangements, the polymer
seal sack is an inflatable fill structure that is fixed, bonded,
attached, or otherwise coupled to the outer surface of a respective
one of the limb stent grafts 214a and 214b that is in the docking
zone 250 when deployed. The locking features 1852 and 1854 (when
inflated) surrounds the outer surface of the proximal end of a
respective one of the limb stent grafts 214a and 214b. In some
arrangements, the locking features 1852 and 1854 are not fixed,
bonded, attached, or otherwise coupled to, and does not surround,
the portion of the respective one of the limb stent grafts 214a and
214b that is outside of the docking zone 250 when deployed. When
inflated by a dedicated fill line or a shared fill line while the
limb stent grafts 214a and 214b are docked in the docking zone 250,
the locking features 1852 and 1854 expand radially from the
proximal ends of the limb stent grafts 214a and 214b toward the
lumen of the laminated stent component 1812 to seal the gutters
between the inner surface of the laminated stent component 1812 and
the outer surface of the limb stent grafts 214a and 214b that are
in the docking zone 250.
[0149] FIG. 19 is a cross-sectional view of an example stent graft
system 1900 deployed across the aneurysm 14 (FIG. 1) according to
various arrangements. Referring to FIGS. 1-3B and 19, the stent
graft system 1900 includes the proximal graft 212, the first limb
stent graft 214a, the second limb stent graft 214b, the inflatable
fill structure 330, the seal component 240, the anchor 245, a
support structure 1920, inflatable structures 1932 and 1934. The
proximal graft 212, the first limb stent graft 214a, the second
limb stent graft 214b, the seal component 240, and the anchor 245
are components of the stent graft system 1900 that are similar to
and confer similar improvements as the corresponding components of
the stent graft system 200. The inflatable fill structure 330 is a
component of the stent graft system 1900 that are similar to and
confer similar improvements as the corresponding components of the
stent graft system 300. As deployed in the aorta 10, the first limb
stent graft 214a and the second limb stent graft 214b can be docked
in the proximal graft 212 (e.g., in the docking zone 250) in the
manner described.
[0150] The stent graft system 1900 differs from the stent graft
system 300 in that the proximal graft 212 includes the support
structure 1920. The support structure 1920 is embedded in the
proximal graft 212. In some arrangements, the support structure
1920 include helix-shaped polymer support rings. The support
structure 1920 is attached, fixed, bonded (e.g., thermally bonded),
sutured, or otherwise coupled to the internal surface of the
proximal graft 212. The support structure 1920 faces or in the
lumen of the proximal graft 212. The support structure 1920 expands
within the lumen of the proximal graft 212 when filled by a
dedicated fill line or a shared fill line shared with another
component of the of the stent graft system 1900. The support
structure 1920, prevents the lumen of the proximal graft 212 from
kinking and collapsing in angulated anatomies and during polymer
filling of the inflatable fill structure 330, which may be soft.
The helix shape of the support structure 1920 can also improve the
joint integrity of the docked limb stent grafts 214a and 214b.
[0151] In some examples, the inflatable fill structure 1932 is
fixed, bonded, attached, or otherwise coupled to the outer surface
of the proximal end of the limb stent graft 214a. The inflatable
fill structure 1932 (when inflated) surrounds the outer surface of
the proximal end of the limb stent graft 214a. In some
arrangements, the inflatable fill structure 1002 is not fixed,
bonded, attached, or otherwise coupled to, and does not surround,
the portion of the limb stent graft 214a that is outside of the
docking zone 250 when deployed. With respect to the limb stent
graft 214b, the inflatable fill structure 1934 is similar to the
inflatable fill structure 1932. When filled using a dedicated fill
line or a shared fill line shared with another component of the of
the stent graft system 1900 while the proximal ends of the limb
stent grafts 214a and 214b are docked into the lumen of the
proximal graft 212 in the docking zone 250, the inflatable fill
structures 1932 and 1934 expand from within the lumen of the
proximal graft 212 that is in the docking zone 250 to seal off the
gutters. The inflatable fill structures 1932 and 1934 expand
radially from the proximal ends of the limb stent grafts 214a and
214b toward the inner surface of the proximal graft 212. As
described, the inflatable fill structure 330, in the inflated
state, can fill up the sac of the aneurysm 14.
[0152] FIGS. 20A, 20B, 20C, 20D, 20E, 20F, 20G, 20H, 20I, 20J, 20K,
and 20L illustrate examples of a proximal graft 2000 according to
various arrangements. Referring to FIGS. 1, 20A, 20B, 20C, 20D,
20E, 20F, 20G, 20H, 20I, 20J, 20K, and 20L, the proximal graft 2000
is a graft component made of graft material. The proximal graft
2000 has a proximal end, a distal end, an internal surface, and an
external surface. The proximal end of the proximal graft 2000 is
the end of the proximal graft 2000 that is closer to or in the
proximal neck region 17 when deployed. The distal end of the
proximal graft 2000 is the end of the proximal graft 2000 that is
closer to the aortic bifurcation 11 when deployed. Typically, the
distal end of the proximal graft 2000 can be placed into the sac of
the aneurysm 14. The proximal graft 2000 has a cylindrical shape
and forms a bore or tubular lumen 2020. The internal surface of the
proximal graft 2000 faces the tubular lumen 2020. The external
surface of the proximal graft 2000 faces walls/surfaces of the
aorta 10 when deployed and faces away from the lumen 2020 of the
proximal graft 2000. Blood is configured to flow through the lumen
2020.
[0153] The proximal graft 2000 includes at least one support
component. Each support component can be embedded in the proximal
graft 2000. In some arrangements, the support component is a
support inflatable fill structure surrounding the proximal graft
2000 such as but not limited to, support rings or balloons made
from a polymer (e.g., PTFE, polyurethane, and so on). In some
arrangements, the support component is attached, fixed, bonded
(e.g., thermally bonded), sutured, or otherwise coupled to the
proximal graft 2000 such that an interior portion (including an
inner surface portion) of each support component is inside of the
lumen 2020 while the remaining exterior portion (including an outer
surface portion) of the support component is outside of the
proximal graft 2000 and is coupled to the external surface of the
proximal graft 2000. In other arrangements, the support component
is attached, fixed, bonded (e.g., thermally bonded), sutured, or
otherwise coupled to the external surface of the proximal graft
2000. The support component can be inflated using a suitable fill
line.
[0154] In FIG. 20A, the proximal graft 2000 includes two support
components 2001 and 2002. The support component 2001 is located at
the proximal end of the proximal graft 2000 while the support
component 2002 is located at the proximal end of the proximal graft
2000.
[0155] In FIG. 20B, the proximal graft 2000 further includes an
anchor 2030. The anchor 2030 is a fixation feature, a fixation
stent frame, and so on. The anchor 2030 anchors, fixes, or attaches
the proximal end of the proximal graft 2000 to the walls/surfaces
of the aorta 10, in the manner described with respect to the anchor
245.
[0156] In FIG. 20C, the proximal graft 2000 further includes an
inflatable structure 2032. The inflatable structure 2032, in the
inflated state, can expand radially toward the surfaces/walls of
the aorta 10 to fill one or more of the sac of the aneurysm 14 (for
sack management), a space between the external surface of the
proximal graft 2000 and the surfaces/walls of the proximal neck
region 17 (for neck sealing), and a space between the external
surface of limb stent grafts (e.g., limb stent grafts 2012 and
2014) and the surfaces/walls of the iliac arteries 12 and 13, in
the manner described herein. The inflatable structure 2032 can be
attached, fixed, bonded (e.g., thermally bonded), sutured, or
otherwise coupled to at least a portion of the external surface of
the proximal graft 2000.
[0157] In FIGS. 20D and 20E, the proximal graft 2000 includes the
support components 2001 and 2002, the anchor 2030, the inflatable
structure 2032, and a bifurcation feature including lumens 2034 and
2035. That is, the proximal graft 2000 is shaped such that the
lumen 2020 that is located at the proximal end of the proximal
graft 2000 becomes bifurcated into the lumens 2034 and 2035 in a
docking zone at the distal end of the proximal graft 2000. The
proximal end and the distal end are opposite ends of the proximal
graft 2000. The limb stent grafts 2012 and 2014 can be docked or
inserted into the lumens 2034 and 2035 in the manner described
herein. The limb stent grafts 2012 and 2014 include respective ones
of the inflatable structures 2016 and 2018 for sac management and
sealing in the manner described herein.
[0158] In FIGS. 20F and 20G, the proximal graft 2000 includes the
support components 2001-2003 and the anchor 2030. The support
component 2003 is between the support components 2001 and 2002
along the proximal graft 2000. The support components 2001-2003 are
spaced apart from each other along the proximal graft 2000. In some
arrangements, the proximal graft 2000 includes inner sleeves or
rings 2044 and 2045 that form lumens 2046 and 2047, respectively,
for receiving the limb stent grafts 2012 and 2014. The inner
sleeves or rings 2044 and 2045 are within the lumen 2020 in a
docking zone between the support components 2002 and 2003. In some
examples, the inner sleeves or rings 2044 and 2045 can be sleeves
or support rings made from a polymer (e.g., PTFE, polyurethane, and
so on). The inner sleeves or rings 2044 and 2045 and the
bifurcation feature can eliminate leakage from the gutters.
[0159] In FIGS. 20H and 20I, the proximal graft 2000 includes the
support components 2001-2003 and the anchor 2030, and without any
bifurcation features or inner sleeves. In FIG. 20J, the proximal
graft 2000 includes the support components 2001-2004 and the anchor
2030. The support components 2003 and 2004 are between the support
components 2001 and 2002 along the proximal graft 2000. The support
components 2001-2004 are spaced apart from each other along the
proximal graft 2000.
[0160] In FIG. 20K, the proximal graft 2000 includes the support
components 2001-2005. The support components 2003-2005 are between
the support components 2001 and 2002 along the proximal graft 2000.
The support components 2001-2005 are spaced apart from each other
along the proximal graft 2000. In FIG. 20L, the proximal graft 2000
includes the support components 2001-2005 and the anchor 2030.
[0161] FIGS. 21A, 21B, 21C, and 21D illustrate examples of a
proximal extension stent graft 2100 according to various
arrangements. Referring to FIGS. 1, 21A, 21B, 21C, and 21D, the
proximal extension stent graft 2100 is a proximal stent graft. The
proximal extension stent graft 2100 has a proximal end, a distal
end, an internal surface, and an external surface. The proximal end
of the proximal extension stent graft 2100 is the end of the
proximal extension stent graft 2100 that is closer to or in the
proximal neck region 17 when deployed. The distal end of the
proximal extension stent graft 2100 is the end of the proximal
extension stent graft 2100 that is closer to the aortic bifurcation
11 when deployed. Typically, the distal end of the proximal
extension stent graft 2100 can be placed into the sac of the
aneurysm 14. The proximal extension stent graft 2100 has a
cylindrical shape and forms a bore or tubular lumen 2120. The
internal surface of the proximal extension stent graft 2100 faces
the lumen 2120. The external surface of the proximal extension
stent graft 2100 faces walls/surfaces of the aorta 10 when deployed
and faces away from the lumen 2120. Blood is configured to flow
through the lumen 2120. The proximal extension stent graft 2100
includes wire-wound stents 2101 that has multiple wire-wound
rings.
[0162] FIG. 21B shows the proximal extension stent graft 2100
further including an anchor 2130 that is similar to the anchor
2030. FIG. 21C shows the proximal extension stent graft 2100
further including an inflatable structure 2132 similar to the
inflatable structure 2032.
[0163] The proximal extension stent graft 2100 shown in FIGS. 21C
and 21D includes encapsulated wire-wound stents 2134 and 2135 in
the docking zone on the distal end of the proximal extension stent
graft 2100. The encapsulated wire-wound stents 2134 and 2135 form
lumens 2144 and 2145 within the lumen 2120. Such encapsulated
wire-wound stents 2134 and 2135 allow limb stent grafts to dock in
the lumen 2120 of the proximal extension stent graft 2100. The
distal ends of the limb stent grafts are oversized (e.g., having a
diameter larger than the diameter of the lumens 2144 and 2145),
such that the limb stent grafts create outward radial force
relative to the encapsulated wire-wound stents 2134 and 2135 to
ensure that the limb stent grafts and the encapsulated wire-wound
stents 2134 and 2135 remain joined.
[0164] In some arrangements, the grafts 2000 and 2100 is a straight
rigid bore. In some arrangements, the grafts 2000 and 2100 is made
from a more flexible PTFE material. In the arrangements in which
the grafts 2000 and 2100 is made from the flexible PTFE material,
the grafts 2000 and 2100 can function like an active seal as blood
pressure inside of the lumens 2020 and 2120 pushes the walls of the
grafts 2000 and 2100 against vessel walls of the aorta 10. Thus,
the active seal is formed between the external surfaces of the
grafts 2000 and 2100 and the vessel walls of the aorta 10.
[0165] FIG. 22A illustrates an example proximal extension
inflatable fill structure 2212 of a system 2200 according to
various arrangements. FIG. 22B is a cross-sectional view of the
system 2200 (FIG. 22A) deployed across the aneurysm 14 (FIG. 1)
according to various arrangements. Referring to FIGS. 1, 22A, and
22B, the system 2200 includes the proximal extension inflatable
fill structure 2212, a first limb stent graft 2213, a second limb
stent graft 2214, an anchor 2245, an inflatable fill structure
2216, and an inflatable fill structure 2218.
[0166] In some example, the proximal extension inflatable fill
structure 2212 is an inflatable fill structure (e.g., an endobag).
In various examples, the proximal extension inflatable fill
structure 2212 has a wider polymer-filled seal zone compared to a
seal ring on other devices. The width of the proximal extension
inflatable fill structure 2212 is denoted as Y as shown. In some
examples, Y is approximately 20 mm. As discussed herein, the wider
proximal extension inflatable fill structure 2212 is forgiving in
placement accuracy, even if the proximal extension stent graft 2000
is placed lower (e.g., 1 mm lower) than an optimal position, the
wider proximal extension inflatable fill structure 2212 can
nevertheless provide a tight seal in the proximal neck region 17.
The wider proximal extension inflatable fill structure 2212 also
has a wider treatment diameter range, which means fewer number of
sizes (and fewer number of SKUs) are needed for treating the entire
vessel treatment range. In some arrangements, a neck length of the
proximal extension inflatable fill structure 2212 is shorter than
the neck lengths of other devices. Furthermore, the wide proximal
extension inflatable fill structure 2212 can improve the neck angle
indication.
[0167] In some arrangements the proximal extension inflatable fill
structure 2212 has or is in communication with a fill line 2206
through which hardenable inflation materials or fill polymers
(e.g., polyesters, PTFE, polyurethane, and the like) are
communicated in liquid form. The proximal extension inflatable fill
structure 2212 can be deployed in the proximal neck region 17 and
inflated therein using the fill line 2206. The proximal extension
inflatable fill structure 2212, in the inflated state, forms a seal
in the proximal neck region 17 to eliminate Type II Endoleaks. The
proximal extension inflatable fill structure 2212 can be filled to
a higher pressure than other devices. The proximal extension
inflatable fill structure 2212 can also provide a more accurate
seal zone and a more circumferential seal in the proximal neck
region 17. The proximal extension inflatable fill structure 2212
can prevent the inflatable fill structures 2216 and 2218 from
prolapsing into the renal arteries 15 and 16 when the inflatable
fill structures 2216 and 2218 are being inflated or when the limb
stent grafts 2213 and 2214 are docking in a docking zone 2250. The
lumens 2202 and 2204 are also located in the proximal neck region
17 when the proximal extension inflatable fill structure 2212 forms
the seal in the proximal neck region 17.
[0168] As shown, the proximal extension inflatable fill structure
2212 from lumens 2202 and 2204 to which the limb stent grafts 2213
and 2214 are docked. The lumens 2202 and 2204 correspond to the
docking zone 2250. When the proximal extension inflatable fill
structure 2212 is in the inflated state, the lumens 2202 and 2204
are fully expanded. The sizes of the fully expanded lumens 2202 and
2204 are slightly smaller than the sizes of the proximal ends of
the limb stent grafts 2213 and 2214. Given the elasticity of the
material of the proximal extension inflatable fill structure 2212
(in the inflated state), the material of the proximal extension
inflatable fill structure 2212 around the lumens 2202 and 2204
forms a seal as the limb stent grafts 2213 and 2214 are docked
therein.
[0169] In various arrangements, the anchor 2245 (a fixation
feature, a fixation stent frame, and so on) anchors, fixes, or
attaches the proximal end of the proximal extension inflatable fill
structure 2212 to the walls/surfaces of the aorta 10, prevents
intrusion of blood into a region between an outer wall and an inner
surface of the aneurysm 14, and improves the transition from the
aorta 10 into the lumens of the proximal extension inflatable fill
structure 2212. In some examples, the anchor 2245 is stitched or
sutured onto the proximal extension inflatable fill structure 2212.
In some examples, the anchor 2245 can include a stent, graft,
and/or other expandable luminal support structure. In some
examples, the anchor 2245 is self-expanding and includes a
suprarenal laser-cut stent with coils attached thereon. In some
examples, the anchor 2245 has a stent shorter than that of some
current stent graft systems to eliminate free crowns. The length of
the anchor 2245 is denoted as X. In some examples, X is
approximately 30 mm or less. A shorter stent allows for a larger
neck angle indication due to an improved stent graft flexibility.
As such, the suprarenal stent of the anchor 2245 is shorter and has
fewer crowns and fewer anchors, allowing the systems 2200 to be
used for smaller treatment sizes. That is, the stent graft system
2200 is a low-profile delivery system that can be used for small
treatment sizes.
[0170] The inflatable fill structure 2216 is fixed, bonded,
attached, or otherwise coupled to at least a portion of the outer
surface of the limb stent graft 2213. The inflatable fill structure
2218 is fixed, bonded, attached, or otherwise coupled to at least a
portion of the outer surface of the limb stent graft 2214. Each of
the inflatable fill structures 2216 and 2218 can be inflated using
a dedicated fill line or a fill line shared with another component
of the system 2200. When inflated, the inflatable fill structures
2216 and 2218 expand radially from the limb stent grafts 2213 and
2214 toward surfaces/walls of the sac of the aneurysm 14. In the
inflated state, the inflatable fill structures 2216 and 2218
surround the limb stent grafts 2213 and 2214, respectively.
[0171] FIG. 23 illustrates an example proximal extension inflatable
structure of a stent graft system according to various
arrangements. Referring to FIGS. 1 and 23, an anchor 2245 (a
fixation feature, a fixation stent frame, and so on) anchors,
fixes, or attaches a proximal end of the proximal extension
inflatable fill structure 2312 to the walls/surfaces of the aorta
10. The proximal extension inflatable fill structure 2312 can be an
element such as but not limited to, the proximal extension
inflatable fill structure 2212. In some examples, the anchor 2345
is stitched or sutured onto the proximal extension inflatable fill
structure 2312. In some examples, the anchor 2345 can include a
stent, graft, and/or other expandable luminal support structure. In
some examples, the anchor 2345 includes stents that are connected
to or extends from the stents 2320 of the proximal extension
inflatable fill structure 2312. As shown, the anchor 2345 includes
hooks or barbs for fixation. In some examples, the anchor 2345 is
self-expanding and includes a suprarenal laser-cut stent with coils
attached thereon. The proximal extension inflatable fill structure
2312, when inflated, can form two lumens 2302 and 2304 similar to
the lumens 2202 and 2204.
[0172] Accordingly, in some arrangements, the stent graft system
described herein includes a wider seal ring that improves placement
accuracy while providing a wider treatment diameter range. In some
arrangements, inflatable fill structures (e.g., endobags) can be
provided to prevent Type II Endoleaks. In some arrangements, a
proximal graft having a large bore diameter is easier to cannulate
than the much smaller contra lumen in some other devices. The
proximal graft having the large bore diameter can also reduce or
eliminates the possibility of cannulating the wrong side (ipsi)
lumen.
[0173] The present technology is not to be limited in terms of the
particular arrangements described in this application, which are
intended as illustrations of aspects of the present technology.
Many modifications and variations of this present technology can be
made without departing from its spirit and scope, as will be
apparent to those skilled in the art. Functionally equivalent
systems and methods within the scope of the present technology, in
addition to those enumerated herein, will be apparent to those
skilled in the art from the foregoing descriptions. Such
modifications and variations are intended to fall within the scope
of the present technology. It is to be understood that this present
technology is not limited to particular systems and methods of
using systems, which can, of course, vary. It is also to be
understood that the terminology used herein is for the purpose of
describing particular arrangements only and is not intended to be
limiting.
* * * * *